The Recall Desk
HighFDA (Devices)·Z-1079-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging

Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units 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 an FDA Class II recall for sterile procedural trays where blades can potentially puncture the sterile packaging foil, creating a risk of sterility compromise. No illnesses or injuries have been reported. Per FDA criteria, risk-of-harm products where injury has not yet been reported warrant a High severity rating.

Plain-English summary

Medline Industries, LP is recalling multiple models of sterile procedural trays across the United States and internationally. The recalled products include dozens of tray configurations used in various surgical procedures, from basic to specialized operations.

The recall is due to the potential for sterile blades within the trays to puncture the outer foil layer of the sterile packaging. This puncture could compromise the sterility of the contents, potentially exposing patients to contaminated surgical instruments during procedures.

The recall affects approximately 62,930 cases (215,456 units) distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Specific affected lot numbers are identified for each tray model in the FDA recall database.

Healthcare facilities should immediately stop using recalled trays and verify product lot numbers against the FDA notice. Facilities should contact Medline Industries with questions about replacement products and proper handling of affected inventory.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Sterile Trays
Hazard
  • blade-puncture
  • sterility-compromise
  • 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. BASIN SET-UP PACK
  • Item Number: BAD079F
  • Case UDI/GTIN: 40889942614135
  • Unit UDI/GTIN: 10889942614134
  • Lot Number: 22IBR514
  • b. LAP CHOLE CDS
  • Item Number: CDS860230D
  • Case UDI/GTIN: 40888277749376
  • Unit UDI/GTIN: 10888277749375
  • Lot Number: 22JMG555
  • c. MAJOR CDS
  • Item Number: CDS980178G
  • Case UDI/GTIN: 40888277906458
  • Unit UDI/GTIN: 10888277906457
  • Lot Number: 22JMG570
  • 22JMC877
  • d. UROLOGY MINOR CDS
  • Item Number: CDS980371L
  • Case UDI/GTIN: 40195327050956
  • Unit UDI/GTIN: 10195327050955

Distribution

Distributed nationwide across the United States.

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