Delta Med NEO DELTA Self Safe 1 IV Catheter Recall: Sterility Risk
Delta Med recalls 5000 units of NEO DELTA Self Safe 1 IV catheters with PUR REF 3708122, Lot 00A1160627 due to possible missing sterility. Consumers should check their catheters for this specific model and lot number.
Recall notice
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Contact the company
What happened, in plain English
Delta Med is recalling 5,000 units of NEO DELTA Self Safe 1 IV catheters with specific reference numbers because they may not be sterile. This could lead to infections if used improperly. Read more at govinfonow.com/recall/62315-delta-med-neo-delta-self-safe-1-iv-catheter-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/62315-delta-med-neo-delta-self-safe-1-iv-catheter-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2300-2021
Cite this page
“Delta Med NEO DELTA Self Safe 1 IV Catheter Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62315-delta-med-neo-delta-self-safe-1-iv-catheter-recall. Based on FDA recall #Z-2300-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2300-2021%22&limit=1).
Why it’s dangerous
The catheters may not be sterile due to issues in the sterilization process. If used without proper sterility, this could lead to infections or other medical complications.
Who’s affected
Patients using IV catheters with the specific model and lot number (PUR REF 3708122, Lot 00A1160627) are affected. Healthcare providers and patients who have this catheter are most at risk.
How to tell if you have this one
Check for the PUR REF 3708122 and Lot 00A1160627 on the catheter packaging or label. The recall covers 5,000 units of NEO DELTA Self Safe 1 IV catheters.
- Brand
Delta Med- Category
Medical device
All 11 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 distribution in the states of FL and MN.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2295-2021 | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272; a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347 | 30,900 units |
| Z-2296-2021 | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572; a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349 | 203,680 units |
| Z-2297-2021 | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573; a) REF 3814773, Lot 11T00118 b) REF 3835773, Lot 11T00119 c) REF 3825773, Lot 11T00120 d) REF 3837773, Lot 11T00121 e) REF 3846773, Lot 11T00122 f) REF 3831473, Lot 11T00142 g) REF 3842473, Lot 11T00143 h) REF 3821473, Lot 11T00146 i) REF 3832473, Lot 11T00147 j) REF 3833473, Lot 11T00148 k) REF 3821573, Lot 11T00177 l) REF 3831573, Lot 11T00178 m) REF 3833573, Lot 11T00179 n) REF 3824773, Lot 11T00230 o) REF 3804773, Lot 11T00231 p) REF 3845773, Lot 11T00232 q) REF 3811473, Lot 11T05089 r) REF 3836773, Lot 11T05136 s) REF 3843473, Lot 11T05166 t) REF 3800473, Lot 11T10007 v) REF 3842573, Lot 12T00180 w) REF 3832573, Lot 11T10015 x) REF 3847773, Lot 11T10016 y) REF 3800573, Lot T1010018 | 229,320 units |
| Z-2298-2021 | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072; a) REF 3832072, Lot 11T80190 b) REF 3810072, Lot 11T80303 c) REF 3842072, Lot 12T80342 d) REF 3852072, Lot 12T80348 | N/A |
| Z-2299-2021 | NEO DELTA Self Safe, I.V. Catheter REF 3738222; REF 3738222, Lot 00A1160625 | 10,000 units |
| Z-2300-2021 | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units; REF 3708122, Lot 00A1160627 | 5000 units |
| Z-2301-2021 | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522; a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638 | 20,000 units |
| Z-2302-2021 | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122; Lot 00A1160806 | 1400 units |
| Z-2303-2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822; a) REF 3738522, Lot 00A2160813 b) REF 3738822, Lot 00A1160822 | 14,000 units |
| Z-2304-2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter:; REF 3738522, Lot 00A2160813 REF 3738822, Lot 00A1160822 | N/A |
| Z-2305-2021 | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W; a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084 | 40,000 units |
What to do — step by step
Check Product Details
Look for PUR REF 3708122 and Lot 00A1160627 on the catheter packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of FL and MN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Minnesota.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-2300-2021 (June 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2300-2021 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.