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Integra LifeSciences Corp. recalls Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary pack
Recalled October 12, 2016 · FDA recall Z-2909-2016 · Integra LifeSciences
Hazard
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. · FDA Class II
Units
14
Sold at
Nationwide Distribution to KS only
Description
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Product
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →