A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set — Class II medical device recall Z-1268-2013
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-1268-2013 |
|---|---|
| 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 | R12J06052, R12J08041, R12J08124, R12J24121, R12K01119, R12K06134, R12K08015, R12K22016, R12K23089, R12K24053, R12K26108, R12K27155 |
Product
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices 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-1268-2013. 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.