FDAClass IIFebruary 15, 2023

Sterile Procedural Trays recall

Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK

Why was Sterile Procedural Trays recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Number: DYNJ82579, Case UDI/GTIN: 40195327198153, Unit UDI/GTIN: 10195327198152, Lot Number: 22HBQ045

Product
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
36 cases (216 units)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Recall date
February 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls