FDA Recalls Medical Kits with Contaminated Pericare Wipes
American Contract Systems Inc. is recalling 1,804 medical kits containing BD CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or infection risk (such as CAUTI) are classified as Severe (Score 4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 1,804 medical convenience kits manufactured by American Contract Systems Inc. These kits contain BD CliniClean Pericare Wipes within BD Urinary Catheter Trays. The specific models affected are MHAH55AM, SPLL54U, and SPVH62P. The products were distributed nationwide in Iowa, Minnesota, Wisconsin, and South Dakota.
The recall was initiated because the pericare wipes may be contaminated with a lubricant used during the manufacturing process. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Additionally, if patients or caregivers dispose of the contaminated wipes and fail to perform perineal care, there is an increased risk of localized infection or catheter-associated urinary tract infection (CAUTI). Consumers and healthcare facilities should stop using these specific 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 ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,804
Distribution
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