FDAClass IIMarch 28, 2018

Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff recall

Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B

Why was Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff recalled?

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot #: a) H1136644, Exp 12/31/2018, UDI (01)00884450305850(17)181231(10)H1136644; b) H1139640, Exp 12/31/18, UDI (01)00884450305850(17)181231(10)H1139640

Product
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Recalling firm
Merit Medical Systems, Inc.
Quantity
30
Distribution
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Recall date
March 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls