Recall of Medical Convenience Kits with Contaminated Pericare Wipes
American Contract Systems Inc. is recalling 1,804 medical convenience kits containing potentially contaminated perineal care wipes. The contamination may cause skin irritation or increase infection risk.
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 involves a risk-of-harm product where injury has not yet been reported, specifically potential skin irritation and increased risk of infection.
Plain-English summary
American Contract Systems Inc. is recalling 1,804 medical convenience kits that contain BD CliniClean Pericare Wipes within BD Urinary Catheter Trays. The affected products include the CARDIAC HEART BUNDLE NS (Model No. LMCH99P) and the OPEN HEART 2 RCH (Model No. RCOH62C). These kits were distributed nationwide in Iowa, Minnesota, Wisconsin, and South Dakota.
The recall is due to the presence of a lubricant used during the manufacturing process, which may contaminate the perineal care wipes. The use of contaminated wipes may lead to localized skin effects, including irritation, erythema, or mild inflammation. Additionally, if healthcare providers 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).
Healthcare facilities and consumers should stop using the affected kits immediately. The specific lot numbers for Model No. LMCH99P are 42-8533511, 42-8669111, 42-8763811, 42-8811311, 42-8825411, and 42-8869411. The specific lot numbers for Model No. RCOH62C are 42-8504411, 42-8561511, 42-8668211, 42-8737811, 42-8797911, and 42-8862511.
The recalled product
- 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
- Manufacturer
- American Contract Systems Inc
- Affected units
- 1,804
Distribution
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