American Contract Systems Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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).
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
UDI-DI 191072236531 Lots 42-8513411 42-8580011 42-8663211 42-8775711 42-8801311 42-8840611 42-8865911
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →