Medline Industries recalls 192,690 Angiographic Control Syringes worldwide after post-market surveillance found a rotating adaptor may unwind. The defect can cause a loose or complete disconnection between syringe and manifold. Stop using immediately and follow recall instructions.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The NAMIC angiographic syringe is used in medical imaging procedures to inject contrast through a catheter. It is part of a hospital or clinic interventional suite.
A rotating adaptor may unwind, causing a loose connection or disconnection with the manifold. This can disrupt contrast delivery and potentially compromise procedure safety.
This recall is not part of a broader industry pattern.
Impact includes potential delays in procedures, need for device replacement, and potential risks from incomplete injections.
FDA enforcement page for Z-1713-2026 and Medline recall notices.
Remedies typically take several weeks.
Keep recall notification, lot numbers, packaging, and any correspondence with Medline.
Product: NAMIC Angiographic Control Syringe. Medline SKUs 70083007 and 70084007; MTS/SYRINGE 8ML SKU 70084017; OEM SKUs 80083007, 80084007; MTO/SYRINGE 8ML SKU 80084017. Distribution: Worldwide, including US, PR, CA, NL, AU, KR, LK, PK, JP, AE, SG, SK.
No specific injuries or incidents are provided in the recall notice.
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