The Recall Desk
HighFDA (Devices)·Z-1078-2023·Announced 2023-02-15

Medline Sterile Surgical Trays Recalled for Potential Blade Puncture of Packaging

Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer 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 is an FDA Class II recall involving sterile surgical instruments where packaging could be compromised, creating a risk of non-sterility. No injuries or illnesses have been reported, placing this in the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Medline Industries, LP is recalling sterile procedural trays sold under multiple product names, including St. Anne's Major Basin Set Up, Single Basin Set, Double Basin Set, Laparotomy Basin, and others. These sterile procedure kits have been distributed worldwide.

Sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging. If the packaging is breached, the sterility of the medical devices within could be compromised.

The affected trays have been distributed nationwide in the United States and internationally to Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Specific affected lot numbers for each product variant are available in the FDA recall notice. Healthcare facilities receiving these trays should contact Medline Industries, LP or refer to the FDA notice for information about their specific units and appropriate handling.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical instruments
Hazard
  • puncture
  • 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 (20)

  • a. ST. ANNE'S MAJOR BASIN SET UP
  • Item Number: DYNJ24628M
  • Case UDI/GTIN: 40195327109135
  • Unit UDI/GTIN: 10195327109134
  • Lot Number: 22JLA323
  • 22ILA590
  • b. SINGLE BASIN SET
  • Item Number: DYNJ35592K
  • Case UDI/GTIN: 40195327110827
  • Unit UDI/GTIN: 10195327110826
  • Lot Number: 22JBW819
  • 22IBK206
  • c. DOUBLE BASIN SET
  • Item Number: DYNJ35596G
  • Case UDI/GTIN: 40195327110810
  • Unit UDI/GTIN: 10195327110819
  • Lot Number: 22JBH675
  • 22HBY465
  • d. LAPAROTOMY BASIN
  • Item Number: DYNJ41354B

Distribution

Distributed nationwide across the United States.

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