—#149294

Product

Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems

FDA product code: JXG — Shunt, Central Nervous System And Components
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K914995
Affected lot / code info: Catalog Number 951303, Lot #0195786 with expiry 05/2019

Why it was recalled

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Root cause (FDA determination)

Process control

Action the firm took

Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution to KS only

Timeline

Recall initiated: 2016-08-23
Terminated: 2017-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.