Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2905-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-08-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2905-2016
Date of alert
2016-08-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Reported risk: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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