FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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.
- Recall number
- Z-1231-2011
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Status
- Terminated
- Initiated
- 2010-12-22
- Posted
- 2011-02-14
- Terminated
- 2012-05-07
- Reason
- Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.
- 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
- 95 units
- Distribution
- Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.
- Lot, serial or model codes
- Catalog Number 901124, Lot Number 162956 510 K - K771529
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GYK
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28