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Lower risk Medical device recall · FDA · Published May 25, 2022

Mckesson Coag-Sense PT/INR Test Kits Recall: Temperature Issues Affecting Effectiveness

Mckesson Medical-Surgical recalls Coag-Sense PT/INR test kits produced between May 30 and August 24, 2021, due to potential temperature excursions affecting product effectiveness. Consumers should check lot codes and contact for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1583-2022Medical deviceMckesson Medical-Surgical ›
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Contact the company

Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233
✎ GovInfoNow plain-language explainer

Mckesson Medical-Surgical is recalling Coag-Sense PT/INR blood test kits made between May 30 and August 24, 2021. The recall is because these kits might have been exposed to temperatures that could reduce their effectiveness, which is important for accurate blood coagulation testing. Read more at govinfonow.com/recall/60583-mckesson-coag-sense-pt-inr-test-kits-recall-temperature-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/60583-mckesson-coag-sense-pt-inr-test-kits-recall-temperature-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1583-2022

Cite this page

“Mckesson Coag-Sense PT/INR Test Kits Recall: Temperature Issues Affecting Effectiveness.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60583-mckesson-coag-sense-pt-inr-test-kits-recall-temperature-issues. Based on FDA recall #Z-1583-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1583-2022%22&limit=1).

The FDA announced on May 25, 2022, that Mckesson Medical-Surgical Inc. Corporate Office is recalling Coag-Sense Professional Blood Coagulation Test kits and a Coagulation Control Kit due to potential temperature excursions affecting product effectiveness. The agency issued recall number Z-1583-2022 for the voluntary Class II action.

How to tell if you have it

  • Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD, Part No. 0356-50
  • Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips, Part No. 03P69-10
  • GTINs: 00861900000336, 00861900000343, 00861900000398, 10861900000395
  • Lot codes distributed between 5/30/2021 - 8/24/2021 (Part No. 0356-50) and 8/20/2021 (Part No. 03P69-10)
  • Sold US Nationwide

The hazard

Facility temperature excursions from June 2021 to August 2021 prior to delivery may have impacted product effectiveness. The recall covers all lots received between 06/01/21 and 9/30/21.

Context

GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has 14 other recalls on record since 2021-06-02. Other recent recalls of similar products include Clearview Strep A Exact II Dipstick Respiratory Kit Recall (2025-07-30), Baxter Infuvite Adult Recall (2025-04-25), and Abbott Diagnostics Probe Conditioning Solution Recall (2025-04-24). Other recent recalls of similar products include Covidien Mon-a-Therm Temperature Probe Recall (2026-04-23) and Medline Convenience Kits Recalls (2026-05-28).

How to tell if you have this one

Check the lot code on the kit, which was distributed between May 30, 2021, and August 24, 2021. The product includes a GTIN number that can help identify the specific batch.

  • Brand
    Mckesson Medical-Surgical
  • Product
    a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50
  • Category
    Medical device
FDA recall event · 55 products

All 55 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
    Ongoing
  • Distribution
    US Nationwide
Recall numberProduct, codes & lotsQuantity
Z-1583-2022a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10.; a. GTIN: 00861900000336; 10861900000395; 00861900000398. Lot codes distributed between 5/30/2021 - 8/24/2021. b. GTIN 00861900000343 Lots Distributed: 8/20/2021 - 8/20/2021a. 27 boxes b. 1 box
Z-1584-2022Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.; GTIN: 15712123000288; 25712123000285 Lot 262801 Lots Distributed: 6/1/2021 - 6/2/20212 cases
Z-1585-2022HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769; GTIN: 03610230005514 Lots Distributed:5/30/2021 - 6/9/20213 each
Z-1586-2022a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933; GTIN: 03610230005736 Lots Distributed: 5/30/2021 - 9/8/2021a. 28 b. 22
Z-1587-2022a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001; GTIN: 10612479218625; 20612479202768 all lots and expiration dates received during July 4th through September 30th, 2021. b. GTIN: 10612479218618; 20612479202751 All lots received between 7/4/21-9/30/21. c. GTIN: 10612479218601; 20612479202744a. 108 b. 838 c. 1225
Z-1588-2022Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875; GTIN: Unknown All lots received between 7/4/21-9/30/211 Btl
Z-1589-2022Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number: I-DUA-157-013. d. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 6-Drug Panel with Adulterants AMP, BZO, COC, mAMP/MET, OPI, THC, (OX, pH, SG) Urine Sample Tests Model Number: I-DUA-167-022. e. Alere Drugs of Abuse Test iCup Dx Pro 2 10-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, OPI300, OXY, MTD, THC (CR, OX, SG) Urine Sample 25 Tests Model Number: I-DXP-2107-01. f. Alere Drugs of Abuse Test iScreen 5-Drug Panel AMP, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: IS5M. g. Instant Technologies, Inc. Drugs of Abuse Test T-Cube 7-Drug Panel AMP50, COC20, mAMP/MET50, OPI40, OXY20, PCP10, THC40 Saliva Sample 25 Tests Model Number: TCUBE-7PCPB. h. Wondfo Drugs of Abuse Test with Adulterants Tcup 14-Drug Panel AMP1000, BAR300, BZO300, BUP10, COC300, mAMP/MET1000, MDMA500, MTD300, MOP(OPI300), OXY100, PCP25, PPX300, TCA1000, THC50 (CR, pH, SG) Urine Sample 25 Tests Model Number: TDOA-1145A3. i. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC, (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCUPA-12CLIA. j. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, THC (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCupA-12BUP300. k. Alere Drugs of Abuse Test E-Z Split Key Cup 6-Drug Panel AMP, BZO, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: DOA-2167-019. l. Alere Drugs of Abuse Test E-Z Split Key Cup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (CR, GL, NI, OX, pH, SG) Urine Sample 25 Tests Model Number: DUD-157-012-019. m. WONDFO USA CO., LTD. Wondfo Drug Test Dip Card Drugs of Abuse Test Tdip Single Drug Buprenorphine (BUP) Urine Sample 25 Tests Model Number: WDBU-114.; a. GTIN: Unknown All lots received between 7/4/21-9/30/21. b. GTIN:00815845020782; 10815845020789 All lots received between 7/4/21-9/30/21. c. GTIN:00858945006072; 10858945006079 All lots received between 7/4/21-9/30/21. d. GTIN: 00858945006133; 10858945006130 All lots received between 7/4/21-9/30/21. e. GTIN: 00817405020355; 00858945006829 All lots received between 7/4/21-9/30/21. f. GTIN: 00858945006508; 10858945006505 All lots received between 7/4/21-9/30/21. g. GTIN: 00817405020959 All lots received between 7/4/21-9/30/21. h. GTIN: 00816862020076; 10816862020073; 00816862029079; 00816862025071 All lots received between 7/4/21-9/30/21. i. GTIN: 00817405021192 All lots received between 7/4/21-9/30/21. j. GTIN: 00858998006104 All lots received between 7/4/21-9/30/21. k. GTIN: 00815845020720; 10815845020727 All lots received between 7/4/21-9/30/21. l. GTIN: 00815845020355; 10815845020352. m. GTIN: 00816862025415.a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. 4 l. 2 m. 3
Z-1590-2022a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish 10 oz. Solution Model Number: 00065035610. d. Alcon Contact Lens Solution Opti Free Replenish 2 oz. Solution Model Number: 00065135658.; a. GTIN: 00047113609126 EA; 20300650358204 CS. All lots received between 7/4/21-9/30/21. b. GTIN: 00300650356350 EA; 20300650356354 CS All lots received between 7/4/21-9/30/21. c. GTIN: 00300650356107 EA; 20300650357207 CS All lots received between 7/4/21-9/30/21. d. GTIN: 00300651356380 EA, 20300650357399 CS All lots received between 7/4/21-9/30/21a. 3 b. 91 c. 45 d. 2
Z-1591-2022Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152; GTIN: 04046964177613; 04046964177620415 eaches
Z-1592-2022B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363; GTIN: 04046964244926; 04046964244940; 040469642449331 Case
Z-1593-2022Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825; GTIN: 00886158012108; 308861580121092 Box
Z-1594-2022Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265; GTIN: 00886158010524; 308861580105251 box
Z-1595-2022Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000; GTIN: 20840067101395; 10840067101398; 008400671013912 Boxes
Z-1596-2022Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604; GTIN: 00363807600515; 10363807600055; 0036380760005813 boxes
Z-1597-2022MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762; GTIN: 0085035500600081 kits
Z-1598-2022Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001; GTIN: a. 00612479240100; 00612479202733. b. 30014613202745. c. 00612479202726; 612479240094. d. 30014613003458. e. 10815845020031, 00815845020034.a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT
Z-1599-2022a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.; GTIN: a. 00884450394984 (EA); 00801741045011 (EA); 10801741045018 (CA); 10884450394981 (CA); 20801741045015 (BX); 20884450394988 (BX). b. 00801741045035 (EA); 00884450394861 (EA); 10801741045032 (CA); 10884450394868 (CA); 20801741045039 (BX); 20884450394865 (BX)a. 123 b. 407
Z-1600-2022MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146; GTIN: 00884450444467; 20884450444461; 108844504444648 Boxes
Z-1601-2022a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests Model Number: 4487. c. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 50 Tests Model Number: 127-50ER; GTIN: a. 10612479219417; 20612479198368. b. 10612479226132; 20612479225569. c. 10612479226125; 20612479225552boxes: a. 20 b. 21 c. 4
Z-1602-2022NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037; GTIN: 09350855000061; 09350855000078; 0935085500002331 Boxes
Z-1603-2022Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G; GTIN: 008404151002128 Eaches
Z-1604-2022TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677); GTIN: 30801902058615; 00801902058614; 20801902058618;5 each
Z-1605-2022STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW; GTIN: 00724995095017; 5072499509501220.25 CS
Z-1606-2022a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.; GTIN: a. 10815845020130; 00815845020133. b. 10815845020093, 00815845020096a. 5 kits b. 12 kits
Z-1607-2022GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000; GTIN: 00650862100013; 206508621000176 each
Z-1608-20223M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165; GTIN: 50707387462593; 00707387462598 EA8 cases
Z-1609-2022MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160; GTIN: 10080196997091; 4008019699709260 each
Z-1610-2022MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200; GTIN: 10080196030873; 400801960308741 Case
Z-1611-2022MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3; GTIN: 10653160244950 EA; 00653160244953 CS3 cases
Z-1612-2022Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157; GTIN: 00888937003765; 208889370037695 each
Z-1613-2022Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610; GTIN: a. 20612479161539; 30612479162472 BX; 40612479161571 CS. b. 20612479161546; 30612479162489 BX; 40612479161588 CSa. 30 each b. 0.3 cs
Z-1614-2022a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LNG LIFE GL (4GL/CS) Catalog # 10-2800; GTIN: a. 10612479150581; 40612479150599 CS. b. 10612479150567; 40612479150575 CS. c. 10612479204406; 40612479204414. d. 00615375005453; 10615375005450 CS; H9711014002. e. 00615375005477; 10615375005474 CS; H9711028002228 gallons b. 38 gal c. 16 qt d. 40 gal e. 124 gal
Z-1615-2022MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047; GTIN: 0081670302181153 each
Z-1616-2022B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116; GTIN: 04046964177538; 0404696417754516 cases
Z-1617-2022a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE COMPLETE 8ML 13"X75" (50/CS) BD Model Number: 364957; GTIN: a. 00382903649518 EA; 30382903649519 PK; 50382903649513. b. 00382903649532; 30382903649533; 50382903649537. c. 00382903649570 EA; 50382903649575 CSa. 25 bx b. 53 bx c. 31 cs
Z-1618-2022a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS VACUTAINER (100/BX) Model Number: 367986. d. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY7.5ML PLAS VACUTAINER (100/BX) Model Number: 367987. e. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY3.5ML PLAS VACUTAINER (100/BX Model Number: 367981. f. BECTON DICKINSON BD Vacutainer TUBE, BLD COL PLAIN RED 10ML GLS VACUTAINER (100/BX 10BX/CS) Model Number: 366430. g. BECTON DICKINSON BD Microtainer SST - Amber TUBE, CAPILLARY CLOT/SEP GLD 400/600UL PLAS MICROT (50/BX) Model Number: 365978. h. BECTON DICKINSON BD Vacutainer CPT NC: 1.0mL FICOLL: 2.0mL TUBE, BLD CPT SOD CIT 8ML (60/CS) Model Number: BD 362761. i. BECTON DICKINSON BD Vacutainer Rapid Serum Tube (RST) Thrombin TUBE, BLD COL CLOT ORG 5ML PETVACUTAINER (100/BX 10BX/CS) Model Number: 368774. j. BECTON DICKINSON BD Vacutainer Buff. Na Citrate 0.109M, 3.2% TUBE, BLD COL SODCIT LTBLU 2.7ML PLAS VACUTAINER (100/BX) Model Number: 363083.; GTIN: a. 00382903679836; 50382903679831. b. 00382903679881; 50382903679886. c. 00382903679867; 50382903679862. d. 00382903679874; 50382903679879, e. 00382903679812; 50382903679817. f. 00382903664306; 30382903664307; 50382903664301. g. 00382903659784; 50382903659789. h. 00382903627615; 50382903627610. i. 00382903687749; 50382903687744. j. 00382903630837; 50382903630832.a. 67 boxes b. 131 c. 51 d. 121 e. 2 f. 38 g. 16 h. 240 i. 17 j. 41
Z-1619-2022a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.; GTIN: a. 10364253111300; 50364253000305; 30364253111304. b. 10612479247670; 40612479247695; 20612479247684.a. 20 Boxes b. 1 bx
Z-1620-2022a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024. e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024. f. METREX RESEARCH CORP DISINFECTANT, ENVIROCIDE 24OZ(12/CS) METREX Model Number: 13-3324. g. METREX RESEARCH CORP Envirocide DISINFECTANT, ENVIROCIDE GL(4/CS)MX-3300 METREX Model Number: 13-3300; GTIN: a. 00615375005446; H97113500020. b. 00615375005309; H97113100824. c. 00615375005385; H9711310002. d. 00615375005361, H97113102422. e. 00615375005415, H97113502426. f. 00615375005354; H97113332427. g. 00615375005378; H11333002150cs b. 38 c. 519gal d. 1671 e. 43.25cs f. 33btl g. unk
Z-1621-2022METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025; GTIN: 00615375006771; 006153750036715 Boxes
Z-1622-2022Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501; GTIN: Not Available2 Boxes
Z-1623-2022a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.; a. GTIN: 00753567101252; 10753567101259. b. GTIN: 809958001158. c. GTIN: Not Available. d. GTIN: unknowna. 772 b. 9 c. 1 d. 1
Z-1624-2022FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015; Not Available3 pk
Z-1625-2022BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C; Not Available3 Boxes
Z-1626-2022BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278; GTIN: 30886158002995; 00886158002994 EA1 Box
Z-1627-2022FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721; Unknown25 Boxes
Z-1628-2022FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006; Not available7 packs
Z-1629-2022BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868; GTIN: a. 15099590233716. b. 15099590233747. c. 15099590671860. d. 15099590671877a. 11 b. 13 c. 15 d. 33
Z-1630-2022CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L; GTIN: 00653160044300, 50653160044305—
Z-1631-2022COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06; GTIN: 8889370044271 each
Z-1632-2022MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL; GTIN: 0064792109670716 each
Z-1633-2022DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202; GTIN: Not available197 boxes
Z-1634-2022Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216; GTIN: Not available135.08 boxes
Z-1635-2022DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250; GTIN: 00616784125039; 00616784125015; '0061678412502217.5 boxes
Z-1636-2022FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712; GTIN: Unknown154 pack
Z-1637-2022MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129; GTIN: Unknown1 case
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Code

    Look for the lot code on the test kit, which was distributed between May 30, 2021, and August 24, 2021.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: May 25, 202212. FDA classified it Class II: Aug 25, 202223. Published in FDA’s Enforcement Report: Aug 31, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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-1583-2022 (May 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1583-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA