Medline Medical Convenience Kits with Namic Manifold Fluid Contamination
Medline Industries is recalling medical convenience kits (HEART CATH PACK-LF, Kit Number DYNJ36478B) due to particulate matter found in the fluid path of the Namic Manifold. Affected kits were distributed in the US and internationally.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device (cardiac catheterization kit component). Per the rubric, FDA Class I recalls receive a minimum severity score of 4 (Severe), as they involve devices where failure could result in serious injury or death.
Plain-English summary
Medline Industries, LP is recalling Medline medical convenience kits labeled HEART CATH PACK-LF (Kit Number/SKU DYNJ36478B) containing Namic Manifolds. The kits have been identified with particulate matter present within the fluid path of the manifolds.
The affected kits have UDI/DI each 10889942814619, UDI/DI case 40889942814610, and Lot Number 26CMC977. Distribution was nationwide in the United States and internationally to Australia, Austria, Canada, Japan, Korea, Netherlands, Singapore, and Slovakia.
Persons who have received or are using these kits should contact Medline Industries, LP for further instructions regarding the recalled product.
The recalled product
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
- Manufacturer
- Medline Industries, LP
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 each 10889942814619
- UDI/DI case 40889942814610
- Lot Number: 26CMC977
Distribution
Part of a larger recall action
This product is one of 11 recalled by Medline Industries, LP 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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