Merit Medical Recalls Performa Cardiac Multipacks Due to Tip Shape Variation
Merit Medical Systems is recalling specific lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
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 is classified as FDA Class II, but the source text describes the defect as a 'slight variation' in tip shape and does not report any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling various lots of Performa Cardiac Multipacks. The recall involves 1,465 units of the product, which are distributed nationwide in the United States. The specific lots affected are 1662386, 1662390, 1662385, 1662387, and 1662391.
The reason for the recall is a slight variation in the tip shape of the JR4.0 catheter included in these multipacks. Angiographic catheters are designed to deliver radiopaque media to selected sites in the vascular system during routine diagnostic procedures.
Healthcare facilities and distributors should check their inventory for the listed lot numbers. If these specific lots are found, they should be removed from use and returned to Merit Medical Systems in accordance with the company's recall instructions.
The recalled product
- Product
- Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1,465
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 (5)
- Lot Numbers: 1662386
- 1662390
- 1662385
- 1662387
- 1662391
Distribution
Distributed nationwide across the United States.
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