The Recall Desk
HighFDA (Devices)·Z-1087-2023·Announced 2023-02-15

Medline Procedural Trays Recalled for Blade Packaging Risk

Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile 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: This Class II medical device recall involves a manufacturing defect where sterile blades may puncture the sterile packaging barrier, compromising sterility and creating a risk of infection. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP (Northfield) is recalling Ambulatory Mini Pack Sterile Procedural Trays due to a manufacturing defect. The recall affects 36 cases containing 216 units, identified by Item Number DYNJ82579, Case UDI/GTIN 40195327198153, Unit UDI/GTIN 10195327198152, and Lot Number 22HBQ045.

The sterile blades within these procedural trays have the potential to puncture the outer foil layer of the sterile packaging. A puncture could compromise the sterile barrier and allow contamination of the medical device, creating a risk of infection if the tray is used for a medical procedure.

The affected trays were distributed worldwide, including throughout the United States and to Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates.

Healthcare facilities and patients in possession of these trays should stop using them immediately and contact Medline Industries for replacement or disposal instructions.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedural Trays
Hazard
  • sharp-puncture
  • sterile-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: DYNJ82579
  • Case UDI/GTIN: 40195327198153
  • Unit UDI/GTIN: 10195327198152
  • Lot Number: 22HBQ045

Distribution

Distributed nationwide across the United States.

Related recalls

Same category