Medline Recalls 419 Surgical Kits Due to Contaminated Component
Medline Industries is recalling 419 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide.
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, which poses a risk of harm. No specific illnesses or injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 419 surgical convenience kits labeled as CMH LITHO MINOR PACK-LF, EAST MAJOR LITHOTOMY, GYN LAPAROTOMY, and UNIVERSAL GYN. 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. Specific lot numbers and UDI/DI codes are available in the structured product information.
Healthcare facilities and consumers should check their inventory for the specific SKUs and lot numbers listed in the recall notice. If the affected kits are found, they should be removed from use and returned to Medline Industries or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 419
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 (15)
- Medline Kit SKU DYNJ54362F
- UDI/DI 10198459794292 (each) 40198459794293 (case)
- Lot Number 26EMF986
- Medline Kit SKU DYNJ900957C
- UDI/DI 10195327599461 (each) 40195327599462 (case)
- Lot Number 25IBP434
- Medline Kit SKU DYNJ906804B
- UDI/DI 10195327433376 (each) 40195327433377 (case)
- Lot Number 26BBA665
- Lot Number 25KBR602
- Lot Number 25JBH531
- Medline Kit SKU DYNJ910195A
- UDI/DI 10198459556838 (each) 40198459556839 (case)
- Lot Number 25KBL876
- Lot Number 25JBS218.
Distribution
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