Lower risk Medical device recall · FDA · Published July 31, 2017
ICU Medical 140" Blood Set Recall: DEHP Contamination Risk
ICU Medical recalls 140" Y-Type Blood Sets with 170-micron filters due to potential DEHP contamination despite labeling as DEHP-free. Affected units may pose health risks during blood collection procedures.
Lower-risk recall
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Contact the company
Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212
What happened, in plain English
ICU Medical is recalling 140-inch blood sets that may contain small amounts of DEHP even though they're labeled as DEHP-free. This could pose health risks during blood collection procedures. Read more at govinfonow.com/recall/73271-icu-medical-140-blood-set-recall-dehp-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73271-icu-medical-140-blood-set-recall-dehp-contamination-risk · Updated September 19, 2026 · FDA enforcement record: FDA #Z-2621-2018
Cite this page
“ICU Medical 140" Blood Set Recall: DEHP Contamination Risk.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73271-icu-medical-140-blood-set-recall-dehp-contamination-risk. Based on FDA recall #Z-2621-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2621-2018%22&limit=1).
Why it’s dangerous
The blood sets are labeled as DEHP-free but may contain small amounts of DEHP, a plasticizer that can be harmful when absorbed through skin during blood collection procedures. DEHP exposure is generally low risk but could be concerning for sensitive individuals.
Who’s affected
Healthcare professionals using blood collection devices and patients undergoing blood draws. Those with specific medical conditions may be at higher risk due to potential DEHP exposure.
How to tell if you have this one
Check for the product name '140" (356 cm) Y-Type Blood Set w/170 Micron Filter' with item numbers B90065, Lot Numbers 3328034, 3347256, 3364748, 3374222, or 3395260.
- Brand
ICU Medical- Category
Medical device
All 53 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
| Recall number | Product, codes & lots |
|---|---|
| Z-2606-2018 | 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 011-C6000, Lot Number 3422869 |
| Z-2607-2018 | 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 011-C6031, Lot Number 3408801, 3408803, 3419007 |
| Z-2608-2018 | 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 011-C6047, Lot Number 3393617, 3419260 |
| Z-2609-2018 | 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 011-C6512, Lot Number 3370933 |
| Z-2610-2018 | 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 061-C6003, Lot Number 3426030 |
| Z-2611-2018 | 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 061-C6028, Lot Number 3414382 |
| Z-2612-2018 | 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 061-C6033, Lot Number 3364588 |
| Z-2613-2018 | Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 081-M9000R, Lot Number 3333003, 3352935, 3365932, 3383035, 3402533, 3413038 |
| Z-2614-2018 | Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number 081-M9000R, Lot Number 3333002,3352936, 3365931, 3380288, 3402532, 3413037 |
| Z-2615-2018 | 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B3000-75, Lot Number 3332350, 3338393, 3343644, 3352549, 3364662, 3365599, 3373893, 3378376, 3387536, 3405268, 3426053, 3428573, 3429586 |
| Z-2616-2018 | 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B30031, Lot Number 3328524, 3338394, 3356920, 3371073, 3373902, 3405269, 3408891, 3423406 |
| Z-2617-2018 | 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B30095, Lot Number 3352422, 3384297, 3391696, 3405273, 3416461, 3432479 |
| Z-2618-2018 | 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B33828, Lot Number 3381499 |
| Z-2619-2018 | 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B5216, Lot Number 3335222, 3356780, 3391845, 3401803, 3405384, 3412076, 3416485, 3416486, 3419516, 3429619, 3429620, 3432660 |
| Z-2620-2018 | 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B90041, Lot Number 3332384, 3374220 |
| Z-2621-2018 | 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B90065, Lot Number 3328034, 3347256, 3364748, 3374222, 3395260 |
| Z-2622-2018 | 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9220, Lot Number 3332388, 3335791, 3343695, 3352567, 3361526, 3364769, 3367356, 3374268, 3391911, 3402549, 3412091, 3416860, 3419590, 3429634 |
| Z-2623-2018 | 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9282, Lot Number 3331696, 3343698, 3344218, 3356703, 3367358, 3379230, 3381358, 3387630, 3391913, 3401825, 3416492, 3416493, 3423450, 3429635 |
| Z-2624-2018 | 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9405, Lot Number 3332396, 3338446, 3347144, 3371146, 3374292, 3405438, 3423451, 3426308 |
| Z-2625-2018 | 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9449, Lot Number 3310515, 3331699, 3331700, 3381369, 3393511, 3401836, 3405441 |
| Z-2626-2018 | 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9561, Lot Number 3328073, 3419595 |
| Z-2627-2018 | 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9622, Lot Number 3327623, 3332856, 3338452, 3351761, 3355549, 3371150, 3373269, 3374329, 3384355, 3387646, 3391948, 3401837, 3405445, 3408966, 3423453 |
| Z-2628-2018 | 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9752, Lot Number 3336049, 3351027, 3352504, 3389728, 3391951, 3412098, 3419605, 3423455 |
| Z-2629-2018 | 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9756, Lot Number 3352552, 3364782, 3371152, 3374346, 3384365, 3396189, 3402557, 3405457, 3408968, 3412099, 3423456, 3426318 |
| Z-2630-2018 | 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9757, Lot Number 3371153 |
| Z-2631-2018 | 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number B9772, Lot Number 3328076, 3343706, 3351028, 3359075, 3364783, 3373275, 3387655, 3391953, 3396191, 3408969, 3423458 |
| Z-2632-2018 | 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number K098-001, Lot Number 3332425, 3364299, 3396263 |
| Z-2633-2018 | 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number MC330414, Lot Number 3401939 |
| Z-2634-2018 | 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number MC33481, Lot Number 3332863, 3344272, 3356773, 3367490, 3371297, 3389253, 3396288, 3419674, 3426437 |
| Z-2635-2018 | 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number MRSB-105, Lot Number 3254697, 3296639, 3309836, 3310605 |
| Z-2636-2018 | 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number MRSB-94, Lot Number 3254698, 3274464, 3281536, 3293649, 3306431, 3307309, 3310606, 3338586 |
| Z-2637-2018 | 80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z0878, Lot Number 69-333-SJ, 69-703-SJ, 70-417-SL, 70-939-SJ, 71-366-Y1, 71-898-Y1, 72-280-HE |
| Z-2638-2018 | 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z1278, Lot Number 70-577-SL, 70-753-SL, 71-103-Y1, 71-193-Y1, 71-536-Y1, 71-704-Y1, 71-989-Y1, 72-409-HE, 72-538-HE, 72-555-HE, 72-928-HE, 73-176-HE, 73-393-HE, 73-623-HE, 73-871-HE, 74-613-JW, 74-713-JW, 75-088-JW |
| Z-2639-2018 | 128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z1340, Lot Number 72-391-HE, 73-994-HE |
| Z-2640-2018 | 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z1440, Lot Number 69-334-SJ, 70-212-SL, 70-913-SL, 70-937-SJ, 71-660-Y1, 72-392-HE, 72-620-HE, 72-905-HE, 73-158-HE, 73-389-HE, 73-625-HE, 73-995-HE, 74-006-JW, 74-307-JW, 74-453-JW, 74-714-JW, 75-430-JW, 75-656-JW, 75-834-JW |
| Z-2641-2018 | 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z1646, Lot Number 69-335-SJ, 71-178-Y1, 73-160-HE, 74-716-JW |
| Z-2642-2018 | 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z1689, Lot Number 69-352-SJ, 69-741-SJ, 70-969-SJ |
| Z-2643-2018 | 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z1726, Lot Number 69-705-SJ, 71-809-Y1 |
| Z-2644-2018 | 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z2001, Lot Number 70-412-SL, 71-175-Y1, 71-693-Y1, 73-163-HE, 73-842-HE, 74-718-JW, 74-991-JW, 75-582-JW |
| Z-2645-2018 | 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z2449, Lot Number 75-760-JW, 75-958-JW |
| Z-2646-2018 | 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z2451, Lot Number 70-208-SL, 71-173-Y1, 72-647-HE, 72-907-HE, 73-629-HE, 74-456-JW, 74-721-JW, 75-434-JW, 75-761-JW, 75-959-JW |
| Z-2647-2018 | 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z2717, Lot Number 72-895-HE, 73-182-HE, 73-874-HE, 74-010-JW, 75-762-JW, 75-839-JW |
| Z-2648-2018 | 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z2819, Lot Number 69-338-SJ, 72-415-HE |
| Z-2649-2018 | 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z2902, Lot Number 69-365-SJ, 69-707-SJ, 70-196-SL, 70-400-SL, 70-759-SL, 70-918-SL, 70-952-SJ, 71-189-Y1, 71-562-Y1, 71-669-Y1, 71-861-Y1, 73-604-HE, 73-877-HE, 74-014-JW, 74-320-JW, 74-463-JW, 74-733-JW, 75-262-JW, 75-420-JW, 75-644-JW, 75-846-JW, 76-096-SJ |
| Z-2650-2018 | 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3172, Lot Number 69-859-JW, 71-573-Y1, 72-148-HE, 73-408-HE, 74-103-JW, 75-322-JW, 75-645-JW, 76-107-SJ |
| Z-2651-2018 | 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3267, Lot Number 71-008-HE, 71-530-Y1, 71-732-Y1, 72-621-HE, 72-929-HE, 73-008-JW, 73-186-HE, 74-459-JW, 74-740-JW, 75-174-JW, 75-637-JW |
| Z-2652-2018 | 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3417, Lot Number 69-204-SJ, 70-920-SL, 71-002-HE, 72-138-HE, 72-648-HE, 73-397-HE, 73-680-HE, 74-012-JW, 74-323-JW, 75-175-JW, 75-860-JW |
| Z-2653-2018 | 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3465, Lot Number 72-139-HE, 73-646-HE, 75-267-JW, 75-437-JW |
| Z-2654-2018 | 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3521, Lot Number 74-350-JW |
| Z-2655-2018 | 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3550, Lot Number 71-567-Y1, 73-648-HE, 73-862-HE, 75-167-JW |
| Z-2656-2018 | 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z3843, Lot Number 70-973-SJ, 71-474-Y1, 73-006-JW, 73-641-HE, 74-340-JW |
| Z-2657-2018 | 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z4088, Lot Number 3429743 |
| Z-2658-2018 | 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.; Item Number Z4089, Lot Number 69-717-SJ, 70-260-SL, 73-197-HE, 74-725-JW |
What to do — step by step
Check Product Labels
Look for item number B90065 or lot numbers 3328034, 3347256, 3364748, 3374222, or 3395260 on the blood set packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 28 states.
FDA distribution: “Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Connecticut, Delaware, Florida, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2621-2018 (July 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2621-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.