Coronary angio packs recalled over Medline syringe rotating adaptor defect
Coronary angio convenience kits are being recalled because they contain Medline Namic syringes whose rotating adaptor may unwind, risking disconnection from the manifold.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor, sold as CORONARY ANGIO PACK under model numbers ANCA80AP and ANCA80AQ, are being recalled. The action covers 7,311 kits.
The impacted kits contain syringes recalled by Medline Industries. The syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and the manifold. According to the notice, this creates a potential risk for biohazard exposure, blood loss, infection or air embolism. The FDA classified the action as Class I, its most serious classification.
Distribution was within the United States, to Minnesota. There was no distribution outside the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the model numbers, UDI-DI codes and lot numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
- Manufacturer
- American Contract Systems Inc
- Affected units
- 7,311
Distribution
Distributed in 1 state:
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