LICOX temperature probe, Model C8.B
FDA device recall Z-0623-05 · posted 2005-03-15 · Terminated
Recall details
- Recalling firm
- Integra Neuro Sciences
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GMW
- Quantity affected
- 19
- 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
- Date initiated
- 2005-01-21
- Date posted
- 2005-03-15
- Date terminated
- 2005-07-13
- Location
- San Diego, CA
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