Medline sterile procedural trays recalled for blade packaging puncture
Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.
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: This is a Class II recall of a sterile medical device where packaging defects could compromise sterility and potentially lead to infection. No illnesses or deaths have been reported, keeping the hazard in the risk-of-harm category without confirmed injury.
Plain-English summary
Medline Industries, LP is recalling LOCAL PACK Sterile Procedural Trays (Item Number DYNJ34129C, Lot Number 22IBG550). Sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging, which could compromise the sterility of the product.
The affected recall includes 8 cases containing 200 units. These trays were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.
The recalled product
- Product
- LOCAL PACK. Sterile Procedural Tray.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
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: DYNJ34129C
- Case UDI/GTIN: 40889942382300
- Unit UDI/GTIN: 10889942382309
- Lot Number: 22IBG550
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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