FDAClass IApril 3, 2024

stay-safe /Safe Lock Catheter Ext. 12 in recall

stay-safe /Safe Lock Catheter Ext. 12 in

Why was stay-safe /Safe Lock Catheter Ext. 12 in recalled?

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

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?

Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.

Product
stay-safe /Safe Lock Catheter Ext. 12 in
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
114,982 eaches
Distribution
Domestic: Nationwide Distribution.
Recall date
April 3, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls