The Recall Desk
HighFDA (Devices)·Z-1085-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Puncture Risk

Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, 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 for a risk-of-harm product where the sterile blade can potentially compromise packaging integrity and product sterility. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed.

Plain-English summary

Medline Industries, LP is recalling Sterile Procedural Trays labeled LS MS PACK. The sterile blade within these kits has the potential to puncture the outer foil layer of the sterile packaging.

The affected product consists of 159 cases distributed worldwide. Distribution includes the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. The recalled product is identified by Lot Number 22IBO057 and Item Number DYNJ81738.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: LS MS PACK
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Trays
Hazard
  • blade-puncture
  • packaging-damage
  • sterility-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: DYNJ81738
  • Case UDI/GTIN: 40195327138258
  • Unit UDI/GTIN: 10195327138257
  • Lot Number: 22IBO057

Distribution

Distributed nationwide across the United States.

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