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.
This recall has been terminated (originally issued February 14, 2011).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- December 22, 2010
- Posted
- February 14, 2011
- Terminated
- May 7, 2012
- Recall Number
- Z-1231-2011
- Quantity
- 95 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.
Distribution
Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.
Lot / Code Info
Catalog Number 901124, Lot Number 162956 510 K - K771529
Root Cause
Labeling mix-ups
Action Taken
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.