Z-2066-2026Class I

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter...

Name: Z-2066-2026 Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter...
Creator: Windstone Medical Packaging, Inc.
Published: 2026-04-02
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2026-04-02 / Open, Classified / root cause: design

FDA source

Windstone Medical Packaging, Inc. began a recall of Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers... on 2026-04-02. FDA classified it as Class I and gives the reason as "Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2066-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-04-02
Posted: 2026-05-08
Recalling firm: Windstone Medical Packaging, Inc.
Product: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Product code: LRO General Surgery Tray
Reason for recall: Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
Root cause tag: design
FDA root cause: Device Design
Action: Firm began notifying consignees via email on April 2, 2026. Notice was titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to check inventory and quarantine affected products. Firm instructed consignees to over-label affected products with a sticker which states that at the time the kit is opened, the affected Medline syringe should be identified and set aside, and that the affected syringe should be rendered unusable and disposed of. Firm will provide labels for any kits that need to be identified.
Quantity in commerce: 150 kits (US only)
Distribution: US Nationwide distribution in the state of Arizona.
Product codes and lots: Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2066-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08

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)