Medline Recalls 263 Surgical Convenience Kits Due to Contamination
Medline Industries is recalling 263 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide in 18 states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device component. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Medline Industries, LP is recalling 263 surgical convenience kits, including Open Heart Packs, Valve CDS, and other procedure-specific kits, due to a potentially contaminated component. The affected products include various SKUs such as CDS840393P, CDS840393Q, and DYNJ911488, with specific lot numbers and UDI/DI codes identified in the recall notice.
The recall covers kits 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. The source text does not specify the exact nature of the contamination or report any illnesses or injuries associated with the use of these kits.
Healthcare facilities and consumers who possess these specific kits should stop using them and contact Medline Industries for instructions on return or disposal. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 263
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 (20)
- Medline Kit SKU CDS840393P
- UDI/DI 10198459405266 (each) 40198459405267 (case)
- Lot Number 26FMA487
- Medline Kit SKU CDS840393Q
- UDI/DI 10198459791673 (each) 40198459791674 (case)
- Lot Number 26GMA017
- Medline Kit SKU CDS980895W
- UDI/DI 10198459123542 (each) 40198459123543 (case)
- Lot Number 25LMG706
- Medline Kit SKU CDS981551G
- UDI/DI 10198459275814 (each) 40198459275815 (case)
- Lot Number 25JBY147
- Lot Number 25JBR361
- Medline Kit SKU CDS982028W
- UDI/DI 10198459385605 (each) 40198459385606 (case)
- Lot Number 25LMH727
- Medline Kit SKU DYNJ906903F
- UDI/DI 10198459504877 (each) 40198459504878 (case)
- Lot Number 25JME689
- Medline Kit SKU DYNJ906904C
Distribution
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