FDA Enforcement
Class I
Ongoing
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Recall: Z-2066-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2066-2026
- Event ID
- 98741
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Windstone Medical Packaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- May 20, 2026
- Initiation Date
- April 2, 2026
- Classification Date
- May 8, 2026
- Address
- 1602 4th Ave N, Billings, MT, 59101-1521, United States
Description
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Reason
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
Code Info
Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
Distribution
US Nationwide distribution in the state of Arizona.
Quantity
150 kits (US only)