Date Initiated by Firm | February 22, 2011 |
Date Posted | May 13, 2011 |
Recall Status1 |
Terminated 3 on May 13, 2011 |
Recall Number | Z-2194-2011 |
Recall Event ID |
58490 |
510(K)Number | K961113 |
Product Classification |
Drills, burrs, trephines & accessories (manual) - Product Code HBG
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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. |
Code Information |
Lot 171237 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
|
For Additional Information Contact | 609-936-6824 |
Manufacturer Reason for Recall | Outer packaging of Combo Kit was mislabeled with an incorrect lot number. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | 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. |
Quantity in Commerce | 7 Kits |
Distribution | Nationwide Distribution -- including the state of New York. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HBG
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