High FDA (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.

Part of a larger recall action

This product is one of 38 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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