FDA DevicesClass I
Convenience kits containing Medline Namic Angiographic Control Syringes with Rot...
Published: May 13, 2026Recall ID: Z-1981-2026Category: devicesCountry: US
Reason for Recall / Hazard
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
Product Description & Identification
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Affected Products
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Additional Source Details
| Field | Value |
|---|---|
| City | Tiffin |
| State | OH |
| Event id | 98720 |
| Address 1 | 85 Shaffer Park Dr |
| Code info | ANCA80AP UDI-DI 191072232168 Lot 42-8146111 ANCA80AQ UDI-DI 191072236678 Lots 42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911 |
| Postal code | 44883-9290 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 7,311 kits |
| Reason for recall | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | |
| Center classification date | 20260506 |
Overview
- Recalling FirmAmerican Contract Systems Inc
- StatusOngoing
- Risk LevelClass I
- DistributionUS distribution to MN. No OUS distribution.