Medline Sterile Procedural Trays Recalled for Packaging Puncture Risk
Medline Industries is recalling ANCILLARY PACK-LF sterile procedural trays because sterile blades in the kits may puncture the outer foil layer of sterile packaging, potentially compromising the sterility of the contents.
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 is a Class II medical device recall where sterile blades may puncture the outer foil layer of sterile surgical kit packaging, potentially compromising sterility. No injuries or illnesses have been reported, placing this in the 'risk-of-harm' category per FDA guidelines.
Plain-English summary
Medline Industries, LP is recalling ANCILLARY PACK-LF sterile procedural trays distributed worldwide, including to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.
The sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging. Puncture of the foil layer could compromise the sterile conditions of the package contents.
The recall affects 48 cases (96 units) with Lot Number 22HME772 (Item Number DYNJ0185290G). Consumers and healthcare facilities with affected units should contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- ANCILLARY PACK-LF. Sterile Procedural Tray.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- puncture-risk
- contamination-risk
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: DYNJ0185290G
- Case UDI/GTIN: 40193489378055
- Unit UDI/GTIN: 10193489378054
- Lot Number: 22HME772
Distribution
Distributed nationwide across the United States.
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