High FDA (Devices)·Z-1091-2023·Announced 2023-02-15

Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture

Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.

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 with a potential risk of harm to patients from compromised sterile packaging on surgical instruments. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario that warrants a High severity rating.

Plain-English summary

Medline Industries, LP is recalling multiple models of sterile surgical procedural trays used in gynecological, urological, and robotic surgical procedures. The trays are affected because sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging.

If the sterile packaging is punctured, the sterility of the surgical instruments could be compromised, potentially exposing patients to contaminated instruments during surgery. This could result in surgical site infections or other complications.

The recall affects 8,064 cases (12,425 units) distributed worldwide to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and United Arab Emirates. Healthcare facilities that have received these trays should remove them from service and contact Medline Industries for instructions on return or replacement.

The recalled product

Product: Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Instrument 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. GYN-URO LAPSCP CDS-LF
Item Number: CDS981583U
Case UDI/GTIN: 40195327209767
Unit UDI/GTIN: 10195327209766
Lot Number: 22JBE255
b. ROBOTIC CDS
Item Number: CDS981882W
Case UDI/GTIN: 40195327144983
Unit UDI/GTIN: 10195327144982
Lot Number: 22IBR176
c. GYN LAPAROSCOPY CDS-LF
Item Number: CDS981988I
Case UDI/GTIN: 40193489744164
Unit UDI/GTIN: 10193489744163
Lot Number: 22KBF564
22JBV989
d. GYN LAPAROSCOPY
Item Number: CDS982032Y
Case UDI/GTIN: 40195327248858
Unit UDI/GTIN: 10195327248857

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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Same hazard · blade puncture