Z-1981-2026Class I

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO...

Name: Z-1981-2026 Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO...
Creator: American Contract Systems Inc
Published: 2026-03-19
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2026-03-19 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems Inc began a recall of Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ on 2026-03-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1981-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-05-06
Recalling firm: American Contract Systems, Inc.
Product: Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Firm notified distributors with an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" dated March 19, 2026, via email. Distributors were instructed to notify end-users. An updated letter with additional kits was sent to the customer on 3/20/26. Customers should quarantine all affected product. Customers may add warning labels to affected ACS kits to ensure all users are aware of prescribed actions that were identified in the Medline recall notice. The warning labels state, "Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure." Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. If you have any questions, contact the Regulatory Affairs Manager, by email: [email protected] or at 419-455-2090.
Quantity in commerce: 7,311 kits
Distribution: US distribution to MN. No OUS distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1981-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1981-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)