Merit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration
Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a configuration error that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Merit Medical Systems, Inc. is recalling 44 units of Custom Dialysis Kit CF-4235 Without Gel. These kits include the Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079.
The recall was initiated because 2-cuff catheters were incorrectly configured and labeled as 1-cuff products before being placed into these dialysis kits. The affected lots are H1190448 (Expiration 7/31/2020) and H1193585 (Expiration 5/30/2019).
The 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 instructions on return or replacement.
The recalled product
- Product
- Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 44
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 (6)
- Lot #: a) H1190448
- Exp 7/31/2020
- UDI (01)00884450328620(17)200731(10)H1190448
- b) H1193585
- Exp 5/30/2019
- UDI (01)00884450328620(17)190530(10)H1193585
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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