Recall Z-2905-2016— Integra LifeSciences Corp.

Name: FDA recall Z-2905-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-23

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-08-23, terminated 2017-03-29. It names one FDA 510(k) clearance: K033698. 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. Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-08-23
Terminated: 2017-03-29
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K033698 — CONTOUR-FLEX VALVE AND SHUNT SYSTEMIntegra Neurosciences Implants S.A.·cleared 2003-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.