PlainRecalls
FDA Devices Moderate Class II Ongoing

Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY

Reported: February 15, 2023 Initiated: November 17, 2022 #Z-1075-2023

Product Description

Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY

Reason for Recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Details

Units Affected
48 cases (96 units)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 48 cases (96 units).
Why was this product recalled?
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 15, 2023. Severity: Moderate. Recall number: Z-1075-2023.