Medical device recalls Moderate risk

Bard Access Systems Inc. recalls PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within…

Recall date
December 28, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0536-2018
FDA classification
Class II
Brand / firm
Bard Access Systems Inc.
Sold / distributed
Distribution US nationwide.

Why it was recalled

Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

Get recall alerts

Free email alert whenever Bard Access Systems Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Bard Access Systems Inc.