FDA-Device2026-10-07Class IIPROCESSING DEFECT

American Contract Systems urinary catheter kits recalled for contaminated pericare wipes

OTHERNationwide distributionMedical devices

What this means

Medical convenience kits containing BD CliniClean Pericare Wipes may have wipes contaminated with lubricant from manufacturing. Using a contaminated wipe could cause skin irritation, or if the wipes are discarded, increase the risk of urinary tract infection.

  • Check if you have model MHRB88AO kits with lot numbers 42-8513411, 42-8580011, 42-8663211, 42-8775711, 42-8801311, 42-8840611, or 42-8865911.
  • Do not use the pericare wipes from recalled kits.
  • Contact your healthcare provider or supplier for replacement or guidance on safe pericare.
  • Report any skin irritation or urinary tract infection symptoms to your doctor.
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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 ROBOTIC PACK - 242561 Model No. MHRB88AO

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3292-2026

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