FDAClass IIApril 2, 2025

Medline procedure kits labeled as: 1) C SCOPE recall

Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702

Why was Medline procedure kits labeled as: 1) C SCOPE recalled?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

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?

1) Pack Number 613034700: UDI/DI 10850009724004 (each) 40850009724005 (case), Lot Number 613034700; 2) Pack Number 613034702: UDI/DI 10850009724066 (each) 40850009724067 (case), Lot Number 613034702

Product
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
90 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
April 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls