Dive Brief:
- Four medtech manufacturers have started recalls of convenience kits due to concerns that they contain recalled angiographic syringes made by Medline.
- The Food and Drug Administration posted recall notices in the past week from American Contract Systems, Medical Action Industries, Aligned Medical Solutions and AVID Medical, instructing customers to remove the affected syringes from kits.
- The companies sent letters to customers notifying them of the problem in March and April, according to the FDA notices. The FDA designated the recalls as Class I, its highest risk, after issuing early alerts last month.
Dive Insight:
Medline began the recall of its Namic angiographic rotating adaptor control syringes in February. The devices, which are used to administer radiographic contrast media in medical imaging, could become loose or disconnected.
The problem could lead to biohazard exposure for clinicians and blood loss and infection for patients, and could cause air to be introduced into the line. Medline had reported four injuries and no deaths as of March 13.
The affected syringes are in cardiac cath packs, coronary angio packs and other kits made by the four companies, which package together surgical instruments, dressings and other components for procedures.
The firms offered similar instructions for customers, telling them to quarantine all affected products and add warning labels to the kits, stating that the affected syringes must be removed and discarded from further use.
If use of the syringes is unavoidable, the affected syringes must be used with “extreme caution and vigilance,” including manual stabilization of the syringe-to-manifold connections and monitoring during the setup and entire procedure, according to the FDA notices.
