Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactu

FDA device recall Z-2588-2010 · posted 2010-09-28 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

The sterility of the product may be compromised. Integra LifeSciences Corp. received a recall notification from Saint-Gobain Performance Plastics, France, contract manufacturer of the Integra Suction Reservoir with Anti-Reflux Valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier.

Action taken

Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached "Recall Acknowledgement. and Return Form" Integra LIfeSciences can be contacted at 609-936-2495.

Root cause

Other

Status

Terminated

Product code

GCY

Quantity affected

313 units

Distribution

Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica,

Date initiated

2010-05-07

Date posted

2010-09-28

Date terminated

2012-08-27

Location

Plainsboro, NJ