FDAAugust 23, 2016device
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed package of lumba...
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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- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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