Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients
Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.
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: Untested medical devices were distributed to patients, creating a risk of harm. No illnesses or injuries have been reported. This meets the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling 17 Flex-Neck Catheter External Repair Kits (Catalog Number CE-1400/A, Lot Number H2586496) due to improper distribution. The units were manufactured for design verification testing and were not validated for use in patients. These untested devices were inadvertently distributed to customers instead of being retained for testing purposes.
The recalled devices were distributed nationwide, with documented distribution in Maryland, Michigan, Ohio, and Texas.
Patients who have received this product should discontinue use and contact Merit Medical Systems, Inc. for instructions on return or replacement.
The recalled product
- Product
- Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 17
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 (1)
- Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496
Distribution
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