Vented Spike Adapter Product Code 2C0471 — Class II medical device recall Z-0109-2014
Terminated recall by Baxter Healthcare Corp., reported 2013-11-06, distributed nationwide. Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
| Recall number | Z-0109-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-08-30 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2017-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 49,344 units |
Product
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
Reason for recall
Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
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-0109-2014. 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.