Non-sterile procedural trays with potential sterile packaging breach
Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.
What this means for you
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: This recall is rated High (3) based on FDA Class II classification and the potential for sterile packaging compromise in a medical device used in procedures. No illnesses or injuries have been reported, and the hazard remains theoretical, which per the rubric caps the score at 3.
Plain-English summary
Medline Industries is recalling non-sterile procedural trays (SPT) containing sterile blades. The recalled product is labeled as MAJOR/MINOR and distributed in cases of 3 units.
The FDA identified a potential hazard: sterile blades in the kits could puncture the outer foil layer and breach the sterile packaging.
The recalled product includes lot 22IBQ980 with item number DYNJ900416M. Approximately 160 cases (480 units total) were distributed to medical facilities in Arkansas, Maryland, Washington, and Wisconsin.
Healthcare providers who received this product should verify their stock against the lot number and item code. Any affected trays should be removed from use and returned to the distributor. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- blade-puncture
- sterility-compromise
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 (4)
- Item Number: DYNJ900416M
- UDI/GTIN Case: 40195327031672
- UDI/GTIN Each: 10195327031671
- Lot Number: 22IBQ980
Distribution
Distributed nationwide across the United States.
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