FDA-Device2018-02-14Class II
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.
Bard Access Systems Inc.
Hazard
Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
Sold states
Distribution US nationwide.
Affected count
53,699 units total
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0536-2018Don't want to check this manually?
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