Medline Recalls 71 Convenience Kits Due to Contaminated Component
Medline Industries is recalling 71 FEMORAL PACK and FEVAR convenience kits 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 product where specific injury or illness reports are not detailed in the source text, fitting the High severity criteria for theoretical or unreported harm risks.
Plain-English summary
Medline Industries, LP is recalling 71 convenience kits labeled as FEMORAL PACK (SKU DYNJ909393A) and FEVAR (SKU DYNJ910295D). The recall was initiated by the manufacturer because the kits contain a potentially contaminated component.
The affected products were distributed nationwide in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI. The specific lot numbers involved are 25ILA297 for the FEMORAL PACK and 26CBT178 for the FEVAR kits.
Consumers should check their inventory for these specific SKUs and lot numbers. If found, they should stop using the products and contact Medline Industries for instructions on return or disposal.
The recalled product
- Product
- Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 71
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 (5)
- 1) Medline Kit SKU DYNJ909393A
- UDI/DI 10195327613945 (each) 40195327613946 (case) Lot Number 25ILA297
- 2) Medline Kit SKU DYNJ910295D
- UDI/DI 10198459586477 (each) 40198459586478 (case)
- Lot Number 26CBT178.
Distribution
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