Recall Z-1981-2026— American Contract Systems Inc
Class I · Ongoing
Class I FDA medical device recall by American Contract Systems Inc, initiated 2026-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ. Reason: 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..
- Recalling firm
- American Contract Systems Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-03-19
- Firm location
- Tiffin, OH, United States
Product description
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.