Device product

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

Z-1143-2018

September 20, 2017

Class II

Product summary

Firm: Merit Medical Systems, Inc.
Event: Event 79426
Status: Terminated
Classification: Class II
Quantity: 30
Official record key: device-enforcement:Z-1143-2018

Official wording

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

Code information: 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

Distribution pattern: United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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