Recall Z-0622-05 ยท GMW Test, Sorbent, Fta-Abs
Integra Neuro Sciences
LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
| Date | Mar 15, 2005 (initiated Jan 21, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE Integra Neurosciences, Nov 24, 2000 |