A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit — Class II medical device recall Z-1271-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-05-15, distributed nationwide. Customers have reported that when separating an individual package from its attached grouping, the adjacent pa
| Recall number | Z-1271-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-05-07 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2017-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA |
| Reason classes | sterility |
| Lot numbers | R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12LL9101, R13A08063, R13A08147, R13A10101, R13A14129, R13A15050, RL3A09137 |
Product
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
Reason for recall
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1271-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.