FDA-Device2026-10-07Class IIPROCESSING DEFECT

American Contract Systems surgical kits recalled for contaminated pericare wipes

OTHERNationwide distributionMedical devices

What this means

Medical convenience kits sold by American Contract Systems contain BD CliniClean pericare wipes that may be contaminated with lubricant from manufacturing. Using a contaminated wipe could cause skin irritation or inflammation, and discarding the wipes might lead to missed perineal care and increased infection risk.

  • Check if you have one of the affected kits (model numbers MHAH55AM, SPLL54U, or SPVH62P) and verify the lot number matches those listed in the recall.
  • Do not use the pericare wipes from the affected kits.
  • Contact your healthcare provider or American Contract Systems for instructions on safe perineal care.
  • Report any skin irritation or signs of infection to your healthcare provider immediately.
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The agency's original wording
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).

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Affected count
1,804 kits total
Manufactured in
85 Shaffer Park Dr, Tiffin, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3294-2026

Also reported as

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