Cardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
Medical Action Industries is recalling cardiovascular procedure kits containing manifolds that may have particulate in the fluid path, which could enter blood circulation and lodge in blood vessels. FDA Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA classified this recall as Class I, which per the rubric corresponds to Critical (score 5).
Plain-English summary
Medical Action Industries, Inc. is recalling Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, cardiovascular procedure kits containing Medline Namic Angiographic Star Off Handle Manifolds. The recall covers 657 units distributed in Arizona and Colorado. Affected lots and expirations are 342513 (1/16/2028), 336758 (9/20/2027), and 338977 (1/16/2028); the UDI-DI is 20809160490416.
The kits contain manifolds that are the subject of another recall. The manifolds may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels. The FDA has classified this recall as Class I.
Healthcare providers and users in the affected distribution area should check whether they have the listed lots. The recall notice does not include specific consumer instructions; users should refer to the FDA recall database entry for further guidance.
The recalled product
- Product
- Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
- Manufacturer
- Medical Action Industries, Inc. 306
- Affected units
- 657
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 (3)
- UDI-DI: 20809160490416. Lot/Expiration: 342513(1/16/2028)
- 336758(9/20/2027)
- 338977(1/16/2028)
Distribution
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