Medline Convenience Kits Recalled for Potentially Contaminated Component
Medline Industries is recalling 15 convenience kits (SKU CDS980375M) due to a potentially contaminated component. The kits were distributed in 18 US states.
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 involves a potentially contaminated component in a medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Medline Industries, LP is recalling 15 convenience kits labeled as LTP CDS-LF (Medline kit SKU CDS980375M). The recall was initiated by the manufacturer because the kits contain a potentially contaminated component.
The affected products are identified by UDI/DI 10198459447327 (each) and 40198459447328 (case), with kit lot number 25JBE079. The products were distributed nationwide in the states of Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin.
Consumers and healthcare facilities should stop using these kits and contact Medline Industries for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10198459447327 (each) 40198459447328 (case)
- kit lot number 25JBE079.
Distribution
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