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 Recall Z-2171-2011 · Posted 2011-05-10
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHBG
Date Initiated2011-02-22
Date Terminated2011-05-10
Product Quantity45 kits
Reason for Recall
Outer box of Monitoring Kit was mislabeled with the incorrect part number.
Firm Action
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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.