FDA-Device2021-07-07Class II

5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

Bard Access Systems Inc.
Hazard

Catheter kits contained the incorrect micro-introducers.

Sold states
U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Affected count
180 units
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1991-2021

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