American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LM
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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 CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0248495 Model No. RCOH62C
- 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
- LMCH99P UDI-DI 191072228147 Lots 42-8533511 42-8669111 42-8763811 42-8811311 42-8825411 42-8869411 RCOH62C UDI-DI 191072230942 Lots 42-8504411 42-8561511 42-8668211 42-8737811 42-8797911 42-8862511
- 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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