FDA recall Z-1994-2021

Bard Access Systems Inc. · Class II · device

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 for recall

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

Distribution

U.S. Nationwide distribution in the state of RI.

Key facts

Status
Terminated
Initiation date
2021-05-19
Report date
2021-07-07
Termination date
2023-03-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1994-2021