Medical device recalls

C.R. Bard, Inc. recalls SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collect…

Recall date
June 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2333-2016
FDA classification
Class III
Brand / firm
C.R. Bard, Inc.
Sold / distributed
Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.

Why it was recalled

Labeling problem

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

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