Namic Preceptor Manifold blood pressure transducers recalled for particulate contamination
Medline Industries is recalling Namic Preceptor Manifold extravascular blood pressure transducers due to the presence of particulate matter within the fluid path. The recall affects 6,390 units distributed nationwide in 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: The FDA classified this as a Class I recall. Per the severity rubric, FDA Class I recalls receive a minimum severity score of 4 (Severe), as they represent a serious hazard where use of the product will cause or may cause serious adverse health consequences or death.
Plain-English summary
Medline Industries, LP is recalling the Namic Preceptor Manifold (Medline Product Number/SKU 64037107), an extravascular blood pressure transducer. The recall was initiated after Medline identified the presence of particulate within the fluid path of the affected manifolds.
A total of 6,390 units have been recalled. The affected devices are identified by UDI/DI 10193489059137 (unit) and 30193489059131 (case), and include the following lot numbers: 89181, 95326, 95254, 102287, 102286, 102706, 105362, 105558, 108608, 112242, 112243, 115437, 118477, 121180, 121645, 122708, 126024, 131603, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, and 193141.
The devices were distributed nationwide in the United States and internationally to AE, AU, CA, JP, KR, NL, SG, and SK. Customers who have received affected units should discontinue use and contact Medline Industries for instructions on replacement or return of the devices.
The recalled product
- Product
- Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
- Manufacturer
- Medline Industries, LP
- Affected units
- 6,390
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 10193489059137
- UDI/DI case 30193489059131
- Lot Numbers: 89181
- 95326
- 95254
- 102287
- 102286
- 102706
- 105362
- 105558
- 108608
- 112242
- 112243
- 115437
- 118477
- 121180
- 121645
- 122708
- 126024
- 131603
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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