FDAClass IISeptember 18, 2024

Medline Convenience kits labeled as: 1) C SCOPE recall

Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE…

Why was Medline Convenience 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?

613034700, Lot Number 20ADD340 ; 613034700, Lot Number 20BDC393 ; 613034700, Lot Number 20BDC472 ; 613034700, Lot Number 20BDC473 ; 613034700, Lot Number 20FDA390 ; 613034700, Lot Number 20FDA896 ; 613034700, Lot Number 20FDA897 ; 613034700, Lot Number 20FDA898 ; 613034700, Lot Number 20FDA896A; 613034700, Lot Number 20JDB120 ; 613034700, Lot Number 21CDA660 ; 613034700, Lot Number 21DDB193 ; 613034700, Lot Number 21IDA396 ; 613034700, Lot Number 21LDB900 ; 613034700, Lot Number 22ADB549 ; 613034701, Lot Number 21CDA617 ; 613034701, Lot Number 21DDB192 ; 613034701, Lot Number 21IDB791 ; 613034701, Lot Number 21JDB094 ; 613034701, Lot Number 22BDB700 ; 613034702, Lot Number 21CDA618 ; 613034702, Lot Number 21DDB222 ; 613034702, Lot Number 21IDB804 ; 613034702, Lot Number 21LDB713

Product
Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Distribution
Worldwide distribution.
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls