FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
- Recall number
- Z-2066-2026
- 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
- Status
- Open, Classified
- Initiated
- 2026-04-02
- Posted
- 2026-05-08
- Terminated
- not on file
- Reason
- 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
- 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
- 150 kits (US only)
- Distribution
- US Nationwide distribution in the state of Arizona.
- Lot, serial or model codes
- Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28