Recall Z-1231-2011 ยท GYK Instrument, Shunt System Implantation
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 cath
| Date | Feb 14, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| 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 (6 |
| Quantity | 95 units |
| Distribution | Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.