Recall Z-1994-2021— Bard Access Systems Inc.

Name: FDA recall Z-1994-2021
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 2023-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire. Reason: Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire..

Recalling firm: Bard Access Systems Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Terminated: 2023-03-31
Firm location: Salt Lake City, UT, United States

Product description

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

Reason for recall

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

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