FDA Medical Device Recalls (openFDA)
American Contract Systems Inc: 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
- Recall number
- Z-3294-2026
- Recalling firm
- 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
- Status
- Open, Classified
- Initiated
- 2026-08-10
- Posted
- 2026-09-25
- Terminated
- not on file
- 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).
- Root cause
- Under Investigation by firm
- Action
- Firm 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
- 1,804 kits total
- Distribution
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJF
- Firm FEI
- 3008492337
- Firm city
- Tiffin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28