American Contract Systems Inc: Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- American Contract Systems Inc
- Product
- Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US distribution to MN. No OUS distribution.
- Recall initiated
- 2026-03-19
- 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
- Product quantity
- 7,311 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tiffin
- State
- OH
- Country
- United States
- Event id
- 98720
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