Z-0622-05

LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

Name: Z-0622-05 LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
Creator: Integra Neuro Sciences
Published: 2005-01-21
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2005-01-21 / Terminated / root cause: sterility

FDA source

Integra Neuro Sciences began a recall of LICOX Complete Brain IMC Probe Kit, Model IM3.ST C on 2005-01-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0622-05
Status: Terminated
Initiated: 2005-01-21
Posted: 2005-03-15
Terminated: 2005-07-13
Recalling firm: Natus Medical Incorporated
Product: LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
Product code: GMW Test, Sorbent, Fta-Abs
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.
Root cause tag: sterility
FDA root cause: 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
Product codes and lots: 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

Product code GMW

K002765Class IILicox Cmp Monitor-Ac3.1, Licox Imc Oxygen Catheters-Cc1,cc1.sb Luicox Imc Introducer Kits-Im,im2,im3,ii1 Licoximc TempeIntegra Neurosciences / cleared 2000-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)