LICOX temperature probe, Model C8.B
This recall has been terminated (originally issued March 15, 2005).
- Company
- Integra Neuro Sciences
- Recall Initiated
- January 21, 2005
- Posted
- March 15, 2005
- Terminated
- July 13, 2005
- Recall Number
- Z-0623-05
- Quantity
- 19
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Lot numbers: 160504 and 240604
Root Cause
Other
Action Taken
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.