Namic Preceptor Manifold extravascular blood pressure transducer
Medline is recalling the Namic Preceptor Manifold due to particulate matter found in the fluid path. The recall affects 760 units distributed in the US and eight other countries.
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 as a Class I recall. Class I recalls indicate a serious health hazard, meeting the threshold for a Severe rating. The presence of particulate matter in the fluid path of a blood pressure transducer poses a risk of device malfunction or patient harm.
Plain-English summary
Medline Industries, LP is recalling the Namic Preceptor Manifold, custom (Medline Product Number 64039307), an extravascular blood pressure transducer. The company identified the presence of particulate matter within the fluid path of the manifolds.
The recalled product includes 760 units distributed in the United States and in Australia, Austria, Canada, Japan, South Korea, Netherlands, Singapore, and Slovakia. The affected lot numbers are 117277, 119982, 122210, 122199, 130129, 133014, 136396, 138613, 139138, 157974, 162399, 164317, 175538, 193515, and 193531. The UDI/DI for individual units is 10193489059205 and for cases is 30193489059209.
Healthcare facilities and users in possession of the recalled manifolds should discontinue use and contact Medline for instructions on return or replacement of the affected product.
The recalled product
- Product
- Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
- Manufacturer
- Medline Industries, LP
- Affected units
- 760
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 (17)
- UDI/DI each 10193489059205
- UDI/DI case 30193489059209
- Lot Numbers: 117277
- 119982
- 122210
- 122199
- 130129
- 133014
- 136396
- 138613
- 139138
- 157974
- 162399
- 164317
- 175538
- 193515
- 193531.
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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