FDA-Device2016-10-12Class II
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
Integra LifeSciences Corp.
Hazard
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Sold states
Nationwide Distribution to KS only
Affected count
18
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2907-2016Don't want to check this manually?
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