Z-1143-2018 Class II Terminated
FDA device recall Z-1143-2018 was initiated by Merit Medical Systems, Inc. on September 20, 2017 and is designated Class II. Reason for recall: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. The recall status is terminated. Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- September 20, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
Product Description
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Reason for Recall
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
Distribution Pattern
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
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