AVID Medical, Inc. — Class II: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (k
AVID Medical, Inc. has initiated a Class II recall for several Halyard medical convenience kits due to a sub-component recall by Medicom involving Ritmed Neurological Sponges. The sponges exhibit unexpected variability in endotoxin levels, affecting various surgical packs including A-P, Posterior, Aneurysm, Spine, Anterior Cervical, and Crani packs.
This recall affects AVID Medical, Inc., healthcare facilities utilizing specific Halyard surgical convenience kits, and quality/regulatory personnel responsible for kit assembly and supplier oversight.
This event highlights the regulatory vulnerability of kit assemblers to upstream component failures. Even if the kit manufacturer's assembly process is controlled, variability in a third-party component—specifically endotoxin levels in neurological sponges—necessitates a broad market withdrawal. This suggests a need for robust traceability systems to link specific component lot failures to finished kit distributions.
Identify and quarantine all affected Halyard medical convenience kits listed in the recall. Review supplier quality agreements to ensure upstream component recalls trigger immediate internal assessments, particularly for kits containing sponges or other sterile components where endotoxin variability may pose risks.
Class II. Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.. Product: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.. Firm: AVID Medical, Inc. (Toano VA United States). Status: Ongoing.
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