FDAAugust 23, 2016device
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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