Recall Ledger

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary... recall (American Contract Systems Inc)

Medical deviceClass IIOngoing

Summary: American Contract Systems Inc is recalling 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: 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).

What is being recalled

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

Why

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).

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota. (states named: Iowa, Minnesota, South Dakota, Wisconsin)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3294-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedAugust 10, 2026
ReportedOctober 7, 2026
CompanyAmerican Contract Systems Inc
Company locationTiffin, OH, United States
Initiated byVoluntary: Firm initiated
Quantity1,804 kits total

More recalls from American Contract Systems Inc · all medical device recalls · recalls from August 2026

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