Recall Z-1991-2021— Bard Access Systems Inc.

Name: FDA recall Z-1991-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-19

Class II · Terminated

Class II FDA medical device recall by Bard Access Systems Inc., initiated 2021-05-19, terminated 2023-01-24. It names one FDA 510(k) clearance: K051672. 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..

Recalling firm: Bard Access Systems Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Terminated: 2023-01-24
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K051672 — POWERPICCBard Access Systems, Inc.·cleared 2005-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.