FDA recall, , High risk
Medline Namic Angiographic Control Syringes Convenience Kits
Convenience kits containing syringes with a rotating adaptor may unwind during use, causing loose or full disconnection.
Summary by Recall Canary from the FDA notice
What happened
American Contract Systems Inc, of Tiffin, Ohio, recalled 7,311 convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor, including CORONARY ANGIO PACK models. The kits contain syringes recalled by Medline Industries because the rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold, posing a potential risk for biohazard exposure, blood loss, infection, or air embolism.
The recall began on March 19, 2026, and was added to the FDA's Enforcement Report on May 6, 2026. The kits were distributed in the United States to Minnesota, with no distribution outside the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI or model number and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor Coronary Angio Pack Model numbers ANCA80AP ANCA80AQ
- UDI-DI
- 191072232168
- 191072236678
- Lot code
- 42-8146111
- ANCA80AQ
- 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
Coronary Angio Pack
- Model number
- ANCA80AP
- ANCA80AQ
Recall details
- Company began the recall
- Sold in
US distribution to Minnesota. No OUS distribution.
- Company
- American Contract Systems IncTiffin, Ohio
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98720
- Recall number
- Z-1981-2026
- Quantity recalled
- 7,311 kits
All recalls from American Contract Systems Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
