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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Integra LifeSciences Corp.: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Agency Publication Date: September 30, 2016
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Affected Products

Product: 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

Catalog Number VC-1, Lot #0195451 with expiry 05/2019

Lot Numbers:
0195451
Product: 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

Catalog Number F75221, Lot #0195486 with expiry 04/2021

Lot Numbers:
0195486
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

Catalog Number 910420, Lot #0195878 with expiry 10/2018

Lot Numbers:
0195878
Product: 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

Catalog Number 910122, Lot #0195615 with expiry 04/2019

Lot Numbers:
0195615
Product: 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

Catalog Number 951303, Lot #0195786 with expiry 05/2019

Lot Numbers:
0195786
Product: 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

Catalog Number 910120A, Lot #0195870 with expiry 05/2019

Lot Numbers:
0195870

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75065
Status: Resolved
Manufacturer: Integra LifeSciences Corp.
Manufactured In: United States
Units Affected: 6 products (10; 9; 18; 1; 14; 1)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.