The Recall Desk
HighFDA (Devices)·Z-1030-2023·Announced 2023-02-08

Non-sterile procedural trays risk sterile packaging breach

Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.

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 sterile packaging breach without reported illnesses or injuries. The hazard represents a risk-of-harm scenario with theoretical contamination risk to users, meeting the rubric criterion for High severity.

Plain-English summary

Medline Industries, LP is recalling non-sterile procedural trays labeled as laparoscopic instruments (Item Number DYNJ900415L) packaged 2 units per case. The recalled product contains sterile blades that are at risk of puncturing the outer foil layer of the packaging.

The potential hazard is that sterile blades within the non-sterile procedural tray kits could puncture the outer foil layer, causing a breach in the sterile packaging. This breach could compromise the sterility of the contents and expose them to contamination.

Approximately 260 cases (520 individual units) have been distributed nationwide, with distribution documented in Arkansas, Maryland, Washington, and Wisconsin. Affected units can be identified by the following lot numbers: 22HBO658 and 22JBV699. The affected case-level UDI/GTIN is 40195327029426, and the individual unit UDI/GTIN is 10195327029425.

Healthcare facilities that have received these affected trays should stop using them immediately and review their procurement records for affected lot numbers. Contact Medline Industries for additional information or return and replacement options.

The recalled product

Product
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays
Hazard
  • packaging-breach
  • contamination-risk

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 (5)

  • Item Number: DYNJ900415L
  • UDI/GTIN Case: 40195327029426
  • UDI/GTIN Each: 10195327029425
  • Lot Numbers: 22HBO658
  • 22JBV699

Distribution

Distributed nationwide across the United States.

Related recalls

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