Merit Medical Recalls Misconfigured Peritoneal Dialysis Catheters
Merit Medical Systems is recalling 30 Flex-Neck Classic Peritoneal Dialysis Catheters because 2-cuff devices were incorrectly configured and labeled as 1-cuff products.
What this means for you
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 and labeling error that poses a risk of harm through improper use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling 30 units of the Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B. The recall involves two specific lots: H1136644 (Expiration 12/31/2018) and H1139640 (Expiration 12/31/18). These devices were distributed in the United States, Austria, Finland, Germany, Ireland, Switzerland, and the United Kingdom.
The recall was initiated because 2-cuff catheters were incorrectly configured and labeled as 1-cuff products. This misconfiguration and mislabeling could lead to improper use of the medical device. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and patients should check their inventory for the specific lot numbers and catalog number listed above. If the affected devices are found, they should be removed from use and returned to Merit Medical Systems, Inc. according to the recall instructions.
The recalled product
- Product
- Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 30
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) 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
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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