Namic Angiographic Manifold recalls due to particulate contamination
Medline Industries is recalling Namic Angiographic Manifolds because particulate has been found in the fluid path of the devices. The affected units were distributed nationwide in the U.S. 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 recall as Class I, which by rule requires a minimum severity score of 4. This is a medical device used in critical cardiovascular procedures (cardiopulmonary bypass), and particulate contamination in the fluid path poses a direct risk of harm during clinical use.
Plain-English summary
Medline Industries, LP is recalling Namic Angiographic Manifolds (Medline Product Number/SKU 64038301), which are used as cardiopulmonary bypass adaptors, stopcocks, manifolds, or fittings. The recall is due to the presence of particulate matter within the fluid path of the manifolds.
Approximately 38,175 units have been distributed in the United States and internationally (including Australia, Canada, Japan, South Korea, the Netherlands, Singapore, and Slovakia). The affected lot numbers are 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, and 191812.
Customers who have received affected units should stop using them immediately and contact Medline Industries for instructions on return or replacement. Healthcare facilities should verify the lot numbers of devices in stock and remove any matching units from service.
The recalled product
- Product
- Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Manufacturer
- Medline Industries, LP
- Affected units
- 38,175
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 10193489059168
- UDI/DI case 30193489059162
- Lot Numbers: 89631
- 92244
- 92464
- 93148
- 94033
- 94851
- 101093
- 101989
- 103550
- 109976
- 112236
- 112333
- 114288
- 115691
- 121707
- 126993
- 137933
- 142147
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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