American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- American Contract Systems Inc
- Product
- Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
- Reason / 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).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Recall initiated
- 2026-08-10
- Code info
- UDI-DI 191072236531 Lots 42-8513411 42-8580011 42-8663211 42-8775711 42-8801311 42-8840611 42-8865911
- Product quantity
- 1,804 kits total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tiffin
- State
- OH
- Country
- United States
- Event id
- 99759
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