—#91622

Product

Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactured by Integra NeuroSciences Implants S.A., Sophia Antipolis Cedex, France; distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.

FDA product code: GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog number: 910-500: lot codes 156618, 155186, 155817, 1561194, 156484, 157140, 157345, 157995, 158188, 158690, 158849, 159155. Catalog number: 31223; lot numbers 158817, 156484. 157140, 157345, 156618; Catalog number: 31253: lot numbers: 158817, 156484, 157345, 158690, 156618.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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, and Sri Lanka.

Timeline

Recall initiated: 2010-05-07
Posted by FDA: 2010-09-28
Terminated: 2012-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.