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 Recall Z-1231-2011 · Posted 2011-02-14
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGYK
Date Initiated2010-12-22
Date Terminated2012-05-07
Product Quantity95 units
Reason for Recall
Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.