FDA Enforcement
Class I
Ongoing
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Recall: Z-2142-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2142-2026
- 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 64039307; Extravascular blood pressure transducer
Reason
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Code Info
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
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Quantity
760 units