The Recall Desk
HighFDA (Devices)·Z-1062-2023·Announced 2023-02-15

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.

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 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
Hazard
  • packaging-puncture
  • sterilization-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: DYNJ34129C
  • Case UDI/GTIN: 40889942382300
  • Unit UDI/GTIN: 10889942382309
  • Lot Number: 22IBG550

Distribution

Distributed nationwide across the United States.

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