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U.S. Department of Health and Human Services

Class 2 Device Recall ACS, American Contract System

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 Class 2 Device Recall ACS, American Contract Systemsee related information
Date Initiated by FirmAugust 10, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3294-2026
Recall Event ID 99759
Product Classification Hysterectomy kit - Product Code OJF
ProductMedical 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
Code Information 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
FEI Number 3008492337
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
419-455-2090
Manufacturer Reason
for Recall		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).
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm began notifying affected distributors via email on August 10, 2026. Distributors were instructed to notify end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. Customers are to add recall labels to affected kits to ensure the impacted component is discarded prior to use. An amended customer letter was sent out on August 28, 2026, which added the following instruction: Users should source alternative cleansing wipes for the impacted product lots and ensure they continue to follow their facility protocols for providing perineal care for patients with urinary catheters.
Quantity in Commerce1,804 kits total
DistributionUS Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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