The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.
The Food and Drug Administration (FDA) issued an early alert regarding a high-risk device issue involving convenience kits from Aligned Medical Solutions. The alert follows a recall of specific angiographic syringes included in the kits that may fail during medical procedures.
Aligned Medical Solutions initiated the urgent medical device recall for convenience kits containing syringes affected by a previous Medline Industries recall of Namic Angiographic Control Syringes with Rotating Adaptor.
According to the FDA, the syringe rotating adaptor on these devices may unwind during use, leading to loose connections or full disconnections between the syringe and manifold. These failures can result in biohazard exposure, blood loss, infection, or the introduction of air into the line, which could cause an air embolism. Such conditions may lead to serious injury or death.
As of March 13, Medline Industries has reported four serious injuries and no deaths associated with this issue.
Affected Products and Components
The recall impacts Aligned Medical Solutions convenience kits, which are packs containing various surgical instruments, dressings, and pharmaceutical components. The specific affected components within these kits include:
- Medline Syringe 10ML Angio W/RA: Part number 80085007
- AMS Syringe 10CC Control Polycarb w/ ROT Adapter: Part number 39331
The affected lot numbers for these components include 70209, 71257, 72311, 75764, 77812, 80915, 86214, 94136, 102993, 108049, 123896, 127096, 135426, 140436, and 189197. The kits are identified as Angio Pack number AMS6908E (lot 214875) and Angio Pack number AMS6908F (lots 215436, 225001, 226706, and 234088).
Required Actions for Healthcare Providers
On April 1, Aligned Medical Solutions sent a letter to affected customers recommending that they immediately identify, segregate, and quarantine all affected products.
The company advises users to apply over-labels to all affected kits on hand. These labels must state that the affected syringes must be removed and discarded from use. The labels should be placed in a prominently visible location that does not cover other critical product information.
Medline Industries further directs customers to remove and destroy all Namic RA Syringes. If use is deemed unavoidable because failure to proceed would result in patient harm, the syringe must be used with extreme caution. This includes manual stabilization of syringe-to-manifold connections and continuous monitoring throughout the entire procedure.
Distributors who have resold or transferred these products are instructed to notify their customers of the recall communication. The FDA is currently reviewing information regarding this issue and will provide updates as significant new information becomes available.
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