Merit Medical Recalls Misconfigured Infant Peritoneal Dialysis Catheter Kits
Merit Medical Systems is recalling 8 dialysis kits containing misconfigured infant catheters. The 1-cuff catheters were incorrectly labeled as 2-cuff products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a labeling and configuration error in a medical device where no illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Merit Medical Systems, Inc. is recalling 8 units of the Custom Dialysis Kit CF-4230 Without Gel. These kits include the Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078.
The recall was initiated because 1-cuff catheters were incorrectly configured and labeled as 2-cuff products before being placed into the dialysis kits. The affected units are identified by Lot # H1190932, with an expiration date of 7/31/2020. The UDI is (01)00884450328613(17)200731(10)H1190932.
The affected products were distributed in the United States, Austria, Finland, Germany, Ireland, Switzerland, and the United Kingdom. Consumers and healthcare providers should stop using these specific kits and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: H1190932
- Exp 7/31/2020
- UDI (01)00884450328613(17)200731(10)H1190932
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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