Custom Procedure Kit Sheath Introducers Mislabeled by Size
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
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: FDA Class II recall involving mislabeling of safety-critical medical device dimensions. The size discrepancy between actual (7F) and labeled (7.5F) sheath introducers represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Custom Procedure Kit, REF: K12T-11077, due to a labeling discrepancy. The product contains 7F sheath introducers that are labeled as 7.5F.
The recall affects 24 units with lot T2908313 (expiring December 1, 2024) that were distributed nationwide to healthcare facilities in Wisconsin, Minnesota, Texas, Pennsylvania, Georgia, Nebraska, California, Arkansas, Mississippi, Massachusetts, Michigan, Ohio, Colorado, Nevada, Oregon, Arizona, North Carolina, and Mexico.
Healthcare providers who received the affected product should verify the actual specifications of the devices and contact Merit Medical Systems, Inc. for instructions on replacement or return of the mislabeled items.
The recalled product
- Product
- Custom Procedure Kit, REF: K12T-11077
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- Affected units
- 24
Distribution
Part of a larger recall action
This product is one of 2 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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