Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S
Summary
The FDA issued a Class I for Custom Convenience Kit containing recalled Medline Namic Angiographic Control Sy by Windstone Medical Packaging, Inc.. Reason: Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use.
Details
Source
Device Recall
External ID
Z-2066-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Lot/Code Info: Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
Quantity Affected: 150 kits (US only)
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.
Distribution
US Nationwide distribution in the state of Arizona.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-02
Company
Billings, MT
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2066-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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