FDA recall Z-1981-2026

American Contract Systems Inc · Class I · device

Product

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

US distribution to MN. No OUS distribution.

Key facts

Status
Ongoing
Initiation date
2026-03-19
Report date
2026-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tiffin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1981-2026