The Recall Desk
HighFDA (Devices)·Z-1074-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard

Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were 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 concerning a potential packaging integrity hazard with no reported illnesses or hospitalizations. The hazard involves the risk of sterile packaging compromise in surgical instruments, meeting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling sterile procedural trays because the sterile blades contained within these surgical kits have the potential to puncture the outer foil layer of the sterile packaging. Puncturing the packaging could compromise the sterility of the surgical instruments.

The recalled products were distributed worldwide, including in the United States and to Canada, Japan, Mexico, Panama, Turks & Caicos, and United Arab Emirates. Approximately 42,593 cases containing 117,470 units were distributed.

Healthcare facilities and consumers who have received these products should discontinue use and contact Medline Industries, LP or the FDA for instructions on returns or next steps.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Sterile Procedural Trays
Hazard
  • blade-puncture
  • 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 (20)

  • a. LAPAROTOMY CDS-LF
  • Item Number: CDS860091A
  • Case UDI/GTIN: 40884389018324
  • Unit UDI/GTIN: 10884389018323
  • Lot Number: 22KMA029
  • 22IMI179
  • 22IME690
  • b. LAPAROSCOPY CDS-LF
  • Item Number: CDS860235I
  • Case UDI/GTIN: 40193489485210
  • Unit UDI/GTIN: 10193489485219
  • Lot Number: 22JMB557
  • c. BASIC LAPAROSCOPY CDS
  • Item Number: CDS920080S
  • Case UDI/GTIN: 40195327209606
  • Unit UDI/GTIN: 10195327209605
  • Lot Number: 22JBO105
  • d. LAPAROSCOPY CDS-LF
  • Item Number: CDS920126AB
  • Case UDI/GTIN: 40193489203296

Distribution

Distributed nationwide across the United States.

Related recalls

Same category