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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- particulate-contamination
- fluid-path-defect
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
Distributed nationwide across the United States.