—#96509

Product

Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USA Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.

FDA product code: GYK — Instrument, Shunt System Implantation
Device class: Class 1
Medical specialty: Neurology
Affected lot / code info: Catalog Number 901124, Lot Number 162956 510 K - K771529

Why it was recalled

Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Integra Life Sciences sent an Urgent Product Recall letter dated December 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine any of the affected product. Contact Integra Customer Service at (800) 654-2873, select option 2 to arrange for product returns. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating the current status of quantities of affected product in their inventory. For questions call (609) 936-2237.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.

Timeline

Recall initiated: 2010-12-22
Posted by FDA: 2011-02-14
Terminated: 2012-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96509. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.