FDA Recalls Medical Kits with Contaminated Pericare Wipes
American Contract Systems Inc. is recalling medical convenience kits containing BD CliniClean Pericare Wipes due to potential lubricant contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a risk of harm (infection/irritation) without reporting specific illnesses or injuries, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays. The recall is initiated by American Contract Systems Inc. and involves 1,804 kits total. These products were distributed nationwide in Iowa, Minnesota, Wisconsin, and South Dakota.
The recall is due to the potential presence of a lubricant used during the manufacturing process within the perineal care wipes. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Use of the contaminated wipes may lead to localized skin effects such as irritation, erythema, or mild inflammation. Additionally, if patients or caregivers dispose of the wipes to avoid using them, the failure to perform perineal care may increase the risk of localized infection or catheter-associated urinary tract infection (CAUTI). Consumers and healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
- Manufacturer
- American Contract Systems Inc
- Affected units
- 1,804
Distribution
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