Medline Recalls 663 Surgical Convenience Kits Due to Contamination
Medline Industries is recalling 663 surgical convenience kits distributed nationwide because they contain a potentially contaminated component.
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 specific injury or illness reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medline Industries, LP is recalling 663 surgical convenience kits, including specific SKUs for major gynecology, lithotomy, open heart, and robotic procedures. The recall was initiated because the kits contain a potentially contaminated component.
The affected 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.
Healthcare facilities and consumers should stop using these kits and contact Medline Industries for further instructions. The specific lot numbers and UDI/DI codes for the affected kits are listed in the official recall documentation.
The recalled product
- Product
- Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 663
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 DYNJG001030C
- UDI/DI 10198459729614 (each) 40198459729615 (case)
- Lot Number 26CLA636
- Medline Kit SKU DYNJT8166
- UDI/DI 10198459697739 (each) 40198459697730 (case)
- Lot Number 26DBG173
- Lot Number 26CBT177
- Medline Kit SKU DYNJ47638B
- UDI/DI 10198459219221 (each) 40198459219222 (case)
- Lot Number 26DBL480
- Lot Number 26CBQ902
- Medline Kit SKU DYNJ900949C
- UDI/DI 10195327076344 (each) 40195327076345 (case)
- Lot Number 25IBR180
- Medline Kit SKU DYNJ903470G
- UDI/DI 10195327678562 (each) 40195327678563 (case)
- Lot Number 26ADA465
- Medline Kit SKU DYNJ908879G
- UDI/DI 10198459377419 (each) 40198459377410 (case)
- Lot Number 25LBU940
Distribution
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