Aligned Medical Solutions Removes Convenience Kits Containing Namic RA Syringes | FDA

FDA Recall: Aligned Medical Solutions Issues Alert for Angio Packs Due to Syringe Failure

Patient safety depends on the reliability of every component in a surgical kit, especially during high-stakes angiographic procedures. Recently, Aligned Medical Solutions (operating as Windstone Medical Packaging) initiated a nationwide recall of specific convenience kits because of a critical failure risk involving the syringes contained within them.

The recall centers on the Medline Namic Angiographic Rotating Adapter (RA) 10CC Syringe. When these components fail, the consequences can be severe, ranging from blood loss to life-threatening air embolisms. For healthcare providers and facility managers, identifying and removing these kits from circulation is an urgent priority.

What Went Wrong? Understanding the Rotating Adapter Failure

The core of this recall is a mechanical failure in the Medline Namic Angiographic Rotating Adapter. During post-market surveillance, it was discovered that the rotating adapter on the 10CC syringe has a tendency to unwind during clinical use.

In a medical setting, a “loose connection” is more than just a nuisance; it’s a breach of the closed system required for safe angiography. If the adapter unwinds completely, the connection between the syringes and the manifold can fail entirely. This creates two primary dangers:

1. Biohazard and Infection Risks

A disconnection exposes the internal sterile environment to the outside air and the clinician to patient fluids. This increases the risk of biohazard exposure for the medical staff and introduces a pathway for infection to enter the patient’s bloodstream.

2. The Danger of Air Embolism

Perhaps the most critical risk is the introduction of air into the line. When a connection fails, air can enter the system and be pushed into the patient’s vasculature. This can lead to an air embolism—a condition where an air bubble blocks a blood vessel, which can cause serious injury or death.

Which Products Are Affected?

The recall specifically targets convenience kits that incorporate the Medline Medical Industries part # 80085007. You can identify the affected products by checking the pack label located inside the sterile barrier of the kit.

The specific recalled items from Aligned Medical Solutions include:

• Angio Pack AMS6908E (Lot B098 / DI Number 0214875)
• Angio Pack AMS6908F (Lot B098 / DI Numbers 0215436, 225001, 226706, 234088)

It’s worth noting that this isn’t an isolated incident with a single packager. The FDA has also noted that American Contract Systems is removing similar convenience kits (such as the Coronary Angio Pack models ANCA80AQ and ANCA80AP) that contain these same problematic Namic RA syringes.

Immediate Actions for Healthcare Facilities

If your facility uses Aligned Medical Solutions or American Contract Systems Angio Packs, you should take the following steps immediately to ensure patient safety:

• Audit Inventory: Check all sterile storage areas for the specific model and lot numbers listed above.
• Segregate and Quarantine: Move all affected kits to a secure, designated area to prevent them from being accidentally used in a procedure.
• Labeling: Apply clear warning labels to any affected kits remaining on hand, explicitly stating that the syringes must be removed and discarded.
• Report Issues: Any adverse reactions or quality problems encountered with these devices should be reported via the FDA’s MedWatch reporting system.

Frequently Asked Questions

Why is this recall considered serious?

The FDA classifies recalls based on the level of risk. Because the failure of this adapter can lead to air embolisms or significant blood loss, it carries a high risk of serious injury or death, making immediate removal from clinical use mandatory.

How do I know if my kit is affected?

The most reliable way to verify your stock is to look at the product label inside the sterile barrier. Check for product codes AMS6908E or AMS6908F and cross-reference the lot numbers provided in the official recall notice.

What should I do if a kit was already used?

If a kit was used and a disconnection occurred, the patient should be monitored for signs of air embolism or infection according to standard clinical protocols, and the event should be reported to the manufacturer and the FDA.

Final Thoughts on Device Vigilance

Medical device recalls are a vital part of the safety ecosystem, but they rely on the swift action of healthcare providers to be effective. The failure of a simple adapter can have catastrophic results in the cath lab. By diligently auditing inventory and following quarantine protocols, facilities can eliminate these risks before they reach the patient.

Stay tuned for further updates as the FDA continues to monitor the removal of these devices from the market.