Windstone Medical Packaging, Inc. recalls Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908EAMS6908FUDI-DI B098AMS6908E07 affected lots214875AMS6908FB098AMS6908F0215436225001226706234088
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the state of Arizona.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2066-2026
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Windstone Medical Packaging, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class I recalls
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man…
- Pulmonary Valve Prosthesis Percutaneously Delivered
- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
