All Recalls

Temperature Abuse: Product exposed to temperature outside specified limits.

Temperature Abuse: Product exposed to temperature outside specified limits.

Temperature Abuse: Product exposed to temperature outside specified limits.

Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam

Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.

Temperature Abuse: Product exposed to temperature outside specified limits.

Temperature Abuse: Product exposed to temperature outside specified limits.

Temperature Abuse: Product exposed to temperature outside specified limits.

Temperature Abuse: Product exposed to temperature outside specified limits.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.

Product sterility is potentially compromised.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

Due to distributing test kits to customers who were not part of a clinical investigation.