Namic Angiographic Manifold recalled for particulate contamination
Medline Industries is recalling the Namic Angiographic Manifold (Product Number 64038402) because particulate matter has been found in the fluid path. This medical device is used in cardiopulmonary bypass procedures.
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 recall is FDA Class I for a medical device used in critical cardiopulmonary bypass procedures. Class I recalls are by definition serious, and particulate contamination in fluid-path medical devices poses risk of patient harm during invasive procedures, placing this at the Severe level.
Plain-English summary
Medline Industries is recalling the Namic Angiographic Manifold, Medline Product Number 64038402, a cardiopulmonary bypass adaptor, stopcock, manifold, or fitting device. The recall was initiated after Medline identified the presence of particulate matter within the fluid path of the manifolds.
Approximately 1,975 units have been distributed nationwide in the United States and internationally to Australia, Austria, Canada, Japan, South Korea, Netherlands, Singapore, and Slovakia. The affected devices carry Lot Numbers 92261, 152082, 163966, and 163256.
Healthcare facilities and providers who have received this product should stop using affected units immediately and contact Medline Industries for further instructions regarding return or replacement. Patients who may have received treatment with the recalled manifold should consult with their healthcare provider if they have questions or concerns about their care.
The recalled product
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,975
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 (6)
- UDI/DI each 10193489059182
- UDI/DI case 30193489059186
- Lot Numbers: 92261
- 152082
- 163966
- 163256.
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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