Recalls / —
—#99461
Product
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
- 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 171237
Why it was recalled
Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Nationwide Distribution -- including the state of New York.
Timeline
- Recall initiated
- 2011-02-22
- Posted by FDA
- 2011-05-13
- Terminated
- 2011-05-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #99461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.