FDA recall Z-1991-2021

Bard Access Systems Inc. · Class II · device

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.

Distribution

U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None

Key facts

Status: Terminated
Initiation date: 2021-05-19
Report date: 2021-07-07
Termination date: 2023-01-24
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-1991-2021