—#98685

Product

Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.

FDA product code: HBG — Drills, Burrs, Trephines & Accessories (Manual)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K961113
Affected lot / code info: Lot number 170314.

Why it was recalled

Outer box of Monitoring Kit was mislabeled with the incorrect part number.

Root cause (FDA determination)

Error in labeling

Action the firm took

Integra LifeSciences Corp. sent an Urgent Product Recall Notification letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine any affected product and arrange for return to Integra by contacting Integra Customer Service Returns at 1-800-654-2873 (choose option 2) to obtain a Return Merchandise Authorization number and place an order for replacement product. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified. For any questions regarding this recall call 609-936-2485.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.

Timeline

Recall initiated: 2011-02-22
Posted by FDA: 2011-05-10
Terminated: 2011-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98685. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.