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American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Mode

Medical DevicesSource: FDA (device) · Date: 2026-10-07

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
American Contract Systems Inc
Product
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P
Reason / hazard
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Recall initiated
2026-08-10
Code info
MHAH55AM UDI-DI 191072236487 Lots 42-8529911 42-8649211 42-8687711 42-8797811 42-8857011 42-8869711 SPLL54U UDI-DI 191072239181 Lots 07-2516111 07-2528611 07-2545611 07-2547911 07-2561411 SPVH62P UDI-DI 191072238771 Lots 07-2544611 12-7436711
Product quantity
1,804 kits total
Voluntary mandated
Voluntary: Firm initiated
City
Tiffin
State
OH
Country
United States
Event id
99759
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