5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions… — Class II medical device recall Z-1991-2021
Terminated recall by Bard Access Systems Inc., reported 2021-07-07, distributed in CT, GA, MA, MI, MT, NJ, NV, NY…. Catheter kits contained the incorrect micro-introducers.
| Recall number | Z-1991-2021 |
|---|---|
| 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 | 2021-05-19 |
| Classified | 2021-06-30 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2023-01-24 |
| Distributed | CT, GA, MA, MI, MT, NJ, NV, NY, VA, WI |
| Quantity | 180 units |
| UPC / GTIN / UDI-DI | 00801741027680 |
| Lot numbers | REEU0201 |
| Model numbers | 3175155 |
Product
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Reason for recall
Catheter kits contained the incorrect micro-introducers.
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-1991-2021. 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.