Recall Z-0407-2013 ยท KAK Probe, Ent
Vital Signs Colorado Inc.
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
| Date | Nov 20, 2012 (initiated Aug 17, 2012) |
| Status | Terminated |
| Reason | There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe. |
| Root cause | Device Design |
| Action | The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and Confirmation form on August 17, 2012 via Fed Ex to its consignees/customers. The letter describes the product, problem and action to be taken. The customers were instructed to do the following: Do not use the Disposable General Purpose 9 French Temperature Probe P/N 1016 or 1016EU; return all unopened product(s) to Vital Signs Devices (VSD) 11039 East Lansing Circle, Englewood, CO 80112-note: replacements and/or refunds discussed in letter are available only in exchange for the return of any unopened product(s); comp |
| Quantity | 243,685 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |