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U.S. Department of Health and Human Services

Class 3 Device Recall LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

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  Class 3 Device Recall LICOX Complete Brain IMC Probe Kit, Model IM3.ST C see related information
Date Initiated by Firm January 21, 2005
Date Posted March 15, 2005
Recall Status1 Terminated 3 on July 13, 2005
Recall Number Z-0622-05
Recall Event ID 31117
510(K)Number K002765  
Product Classification Test, Sorbent, Fta-Abs - Product Code GMW
Product LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
Code Information Lot numbers: 2506, 3904, 04779, 04795, 04835, 14716, 18141, 19059, 21044, 28800, 28806, 28806A, 47814, 050105, 619202, 619406, 619419, 619466, 619536, 619593, 619632, 619675, 619733, 619886, 619999, 620331/1
Recalling Firm/
Manufacturer		 Integra Neuro Sciences
5955 Pacific Center Blvd
San Diego CA 92121-4309
For Additional Information Contact Nancy A. Mathewson
858-455-1115 Ext. 185
Manufacturer Reason
for Recall		 LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
FDA Determined
Cause 2		 Other
Action LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
Quantity in Commerce 823
Distribution LA, CA, CO, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, NE, NY, OH, OR, PA, SD, TN, TX, VA
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = GMW and Original Applicant = INTEGRA NEUROSCIENCES
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