Recall Z-0407-2013— Vital Signs Colorado Inc.

Name: FDA recall Z-0407-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-17

Class II · Terminated

Class II FDA medical device recall by Vital Signs Colorado Inc., initiated 2012-08-17, terminated 2013-06-14. It names 3 FDA 510(k) clearances: K944949, K925791, K822277. Product: Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature. Reason: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe..

Recalling firm: Vital Signs Colorado Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-17
Terminated: 2013-06-14
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

3 on FDA's record

K944949 — GENERAL ANESTHESIA SYSTEMVital Signs, Inc.·cleared 1994-11-14
K925791 — EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSORDeroyal Industries, Inc.·cleared 1994-02-25
K822277 — ROSEN'S STAPES NEEDLE EXPLORERKelleher Corp.·cleared 1982-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

Reason for recall

There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

Data sourced from openFDA. This site is unofficial and independent of the FDA.