Medline Medical Convenience Kits with Namic Manifold Recalled
Medline is recalling 107 medical convenience kits containing Namic Manifold (TAVI) due to particulate found in the fluid path. The kits were distributed nationwide 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: The FDA has classified this as a Class I recall. Per the severity rubric, FDA Class I recalls are classified as Severe (score 4) unless there are reported deaths, which would elevate it to Critical.
Plain-English summary
Medline Industries, LP is recalling Medline medical convenience kits containing Namic Manifold, labeled as TAVI (Kit Number/SKU DYNJ904981C). The recall affects 107 kits that were distributed in the United States and internationally to Australia, Canada, Japan, South Korea, the Netherlands, Singapore, and Slovakia.
Medline identified the presence of particulate within the fluid path of the Manifolds. Affected lot numbers are: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, and 24GBM624. The UDI/DI for each unit is 10193489475135, and the UDI/DI for cases is 40193489475136.
Patients, healthcare providers, and healthcare facilities that have received these kits should discontinue use and contact Medline Industries, LP for further instructions regarding return or replacement of affected units.
The recalled product
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
- Manufacturer
- Medline Industries, LP
- Affected units
- 107
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 (8)
- UDI/DI each 10193489475135
- UDI/DI case 40193489475136
- Lot Numbers: 23GBR742
- 23IBC951
- 23JBM554
- 23LBK506
- 24BBO670
- 24GBM624.
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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