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.
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 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
- Hazard
- particulate-contamination
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
Distributed nationwide across the United States.