Custom Dialysis Kit CF-4230 Without Gel recall
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Why was Custom Dialysis Kit CF-4230 Without Gel recalled?
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
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 #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932
- Product
- Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 8
- Distribution
- United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)