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 Recall Z-2194-2011 · Posted 2011-05-13
Advertisement
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHBG
Date Initiated2011-02-22
Date Terminated2011-05-13
Product Quantity7 Kits
Reason for Recall
Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- including the state of New York.
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.
Advertisement