FDA Device recall Z-1991-2021
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer by Bard Access Systems, citing catheter kits contained the incorrect micro-introducers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1991-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-19 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Access Systems |
| Distribution | CT, GA, MA, MI, MT, NJ, NV, NY, VA, WI |
Product
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Reason
Catheter kits contained the incorrect micro-introducers.
Identifiers
| code_info | Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1991-2021%22
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