Z-1981-2026 Class I Ongoing
FDA device recall Z-1981-2026 was initiated by American Contract Systems Inc on Mar 19, 2026 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 7,311 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2026
- Initiation Date
- Mar 19, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,311 kits
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.
Distribution Pattern
US distribution to MN. No OUS distribution.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1981-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026