PowerPICC Provena Catheters — Class II medical device recall Z-0536-2018
Terminated recall by Bard Access Systems Inc., reported 2018-02-14, distributed nationwide. Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension le
| Recall number | Z-0536-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems Inc., Salt Lake City, UT, United States |
| Recall initiated | 2017-12-28 |
| Classified | 2018-02-06 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2021-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 53,699 units |
| Reason classes | packaging |
| Serial numbers | CK000114A, CK000283A, CK000759, CK000765, CK000767, CK000770, S0173108PD, S0274108PD, S1173108, S1173108D, S1173108PD, S1274108, S1274108D, S1274108PD, S1274118, S3173108, S3173108D, S3173108PD, S3173118, S3173335, S3173335P, S3173355, S3173355P, S3274108, S3274108D and 14 more |
Product
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
Reason for recall
Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
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-0536-2018. 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.