Dual Luer Lock Cap The device is intended for use as a cap for male… — Class II medical device recall Z-0143-2014
Terminated recall by Baxter Healthcare Corp., reported 2013-11-13, distributed nationwide. The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate
| Recall number | Z-0143-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-09-10 |
| Classified | 2013-11-06 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2015-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 628,992 units |
| Reason classes | specification failure |
Product
Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Reason for recall
The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
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-0143-2014. 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.