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.
This recall has been terminated (originally issued May 10, 2011).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- February 22, 2011
- Posted
- May 10, 2011
- Terminated
- May 10, 2011
- Recall Number
- Z-2171-2011
- Quantity
- 45 kits
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Outer box of Monitoring Kit was mislabeled with the incorrect part number.
Distribution
Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.
Lot / Code Info
Lot number 170314.
Root Cause
Error in labeling
Action Taken
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.