Namic Angiographic Manifold Recalled for Particulate Contamination
Medline Industries is recalling approximately 7,075 units of the Namic Angiographic Manifold (SKU 64038200) due to particulate found in the fluid path. The manifold is used in cardiopulmonary bypass procedures and is distributed across 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, which mandates a severity score of at least 4 per the rubric. No reported illnesses or injuries are stated in the source material, preventing a Critical rating, but the Class I designation itself reflects serious potential for adverse health consequences in a critical medical device used in cardiopulmonary bypass procedures.
Plain-English summary
Medline Industries is recalling the Namic Angiographic Manifold, a cardiopulmonary bypass adaptor, stopcock, manifold, and fitting (Medline Product Number/SKU 64038200). Approximately 7,075 units are affected. The company has identified the presence of particulate within the fluid path of the manifolds.
The recalled units were distributed across the United States and internationally to Australia, Austria, Canada, Japan, Korea, the Netherlands, Singapore, and Slovakia. Specific lot numbers identified in the recall are: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, and 168053.
This is an FDA Class I recall. Healthcare providers and patients who have received these devices should contact Medline Industries or their healthcare provider for further guidance on appropriate steps to take regarding affected units.
The recalled product
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Manufacturer
- Medline Industries, LP
- Affected units
- 7,075
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 (20)
- UDI/DI each 10193489059144
- UDI/Di case 30193489059148
- Lot Numbers: 90184
- 94779
- 97786
- 106351
- 108597
- 109876
- 114056
- 114989
- 115459
- 115931
- 116358
- 116865
- 118245
- 122974
- 126077
- 127795
- 129531
- 130557
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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