Z-1231-2011

Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra...

Name: Z-1231-2011 Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra...
Creator: Integra LifeSciences Corp.
Published: 2010-12-22
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-12-22 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921... on 2010-12-22. The reason FDA records is "Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1231-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-02-14
Terminated: 2012-05-07
Recalling firm: Integra LifeSciences Corporation
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.
Product code: GYK Instrument, Shunt System Implantation
Reason for recall: Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 95 units
Distribution: Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.
Product codes and lots: Catalog Number 901124, Lot Number 162956 510 K - K771529

Product code GYK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)