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Integra LifeSciences Corp. recalls Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet
Recalled October 12, 2016 · FDA recall Z-2907-2016 · 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
18
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
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →