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

FDA device recall Z-1231-2011 · posted 2011-02-14 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

GYK

Quantity affected

95 units

Distribution

Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.

Date initiated

2010-12-22

Date posted

2011-02-14

Date terminated

2012-05-07

Location

Plainsboro, NJ