FDA-Device2016-10-12Class II
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
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
1
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2908-2016Don't want to check this manually?
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