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Terminated

LICOX temperature probe, Model C8.B

FDA Recall Z-0623-05 · Posted 2005-03-15

Recalling FirmIntegra Neuro Sciences
Recall StatusTerminated
Product CodeGMW
Date Initiated2005-01-21
Date Terminated2005-07-13
Product Quantity19

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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