FDAClass IIFebruary 15, 2023

UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray recall

UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray

Why was UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray 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: DYNJ52230, Case UDI/GTIN: 40889942252269, Unit UDI/GTIN: 10889942252268, Lot Number: 22IBJ862

Product
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
20 cases (120 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