FDA Enforcement
Class I
Ongoing
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Recall: Z-2141-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2141-2026
- Event ID
- 98735
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 20, 2026
- Initiation Date
- March 24, 2026
- Classification Date
- May 8, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Reason
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code Info
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, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, 193141.
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Quantity
6390 units