openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 6
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information
Catalog Number VC-1, Lot #0195451 with expiry 05/2019
Distribution pattern
Nationwide Distribution to KS only
device · product 2 of 6
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information
Catalog Number F75221, Lot #0195486 with expiry 04/2021
Distribution pattern
Nationwide Distribution to KS only
device · product 3 of 6
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
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information
Catalog Number 910420, Lot #0195878 with expiry 10/2018
Distribution pattern
Nationwide Distribution to KS only
device · product 4 of 6
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
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information
Catalog Number 910122, Lot #0195615 with expiry 04/2019
Distribution pattern
Nationwide Distribution to KS only
device · product 5 of 6
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information
Catalog Number 951303, Lot #0195786 with expiry 05/2019
Distribution pattern
Nationwide Distribution to KS only
device · product 6 of 6
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 lumbar catheter and External drainage system is finally packaged in a cardboard box. Intended for CSF external drainage
