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Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

Class I
Recalling firm
American Contract Systems Inc
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.
Affected products (lot / model / serial)
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
Units affected
7,311 kits
Distribution pattern
US distribution to MN. No OUS distribution.
Firm location
Tiffin, OH, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-1981-2026
Recall initiated
March 19, 2026
FDA classification date
May 6, 2026
FDA report date
May 13, 2026
FDA event ID
98720
Last updated on HTM Vibe
July 24, 2026
View on openFDA