Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture
Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.
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: FDA Class II recall involving potential sterility compromise of surgical instruments with theoretical risk of harm. No illnesses or injuries have been reported; the hazard remains potential rather than realized.
Plain-English summary
Medline Industries, LP is recalling sterile procedural trays labeled as the DR MOTT DRAPE PACK due to a potential safety issue with sterile blades within the kits.
The issue is that sterile blades within the trays have the potential to puncture the outer foil layer of the sterile packaging. This puncture could compromise the sterility of the surgical instruments, potentially affecting patient safety during procedures.
The recall affects units with lot number 22JLA859 that were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. No illnesses or injuries related to this issue have been reported.
Healthcare facilities and users of these trays should stop using affected products and contact Medline Industries or the FDA with any questions or concerns.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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: DYNJ42065B
- Case UDI/GTIN: 40888277893550
- Unit UDI/GTIN: 10888277893559
- Lot Number: 22JLA859
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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