Medline Recalls Surgical Convenience Kits Due to Contaminated Components
Medline Industries is recalling 169 surgical convenience kits nationwide because they contain potentially contaminated components.
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 involves a medical device with a potentially contaminated component, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria for risk-of-harm products.
Plain-English summary
Medline Industries, LP is recalling 169 surgical convenience kits distributed across 18 U.S. states. The affected products include various gynecological and abdominal surgery kits, such as LAVH, GYN ABDOMINAL CDS, and GYN LAP HYSTERECTOMY CDS kits, identified by specific SKUs and lot numbers.
The recall was initiated because the kits contain a potentially contaminated component. The source text does not specify the nature of the contamination or the specific component involved. No illnesses or injuries have been reported in the provided text.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions or a return. The kits were distributed in Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin.
The recalled product
- Product
- Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 169
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 (17)
- Medline Kit SKU CDS982273U
- UDI/DI 10198459385827 (each) 40198459385828 (case)
- Lot Number 25LBR956
- Lot Number 25KBP729
- Medline Kit SKU CDS982654L
- UDI/DI 10195327306830 (each) 40195327306831 (case)
- Lot Number 26EBN087
- Medline Kit SKU CDS982662Q
- UDI/DI 10195327306793 (each) 40195327306794 (case)
- Lot Number 25JBK543
- Medline Kit SKU DYNJ54382F
- UDI/DI 10198459794285 (each) 40198459794286 (case)
- Lot Number 26FMC227
- Medline Kit SKU DYNJ903467L
- UDI/DI 10198459293207 (each) 40198459293208 (case)
- Lot Number 26DMK551
- Lot Number 26DMB880.
Distribution
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