Z-0407-2013Class II

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

Name: Z-0407-2013 Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Creator: Vital Signs Colorado Inc.
Published: 2012-08-17
License: https://open.fda.gov/license/

Vital Signs Colorado, Inc. / initiated 2012-08-17 / Terminated / root cause: design

FDA source

Vital Signs Colorado Inc. began a recall of Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature on 2012-08-17. FDA classified it as Class II and gives the reason as "There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0407-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-17
Posted: 2012-11-20
Terminated: 2013-06-14
Recalling firm: Vital Signs Colorado, Inc.
Product: Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Product code: KAK Probe, Ent
Reason for recall: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Root cause tag: design
FDA 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); complete and return the URGENT MEDICAL DEVICE CORRECTION CONFIRMATION via fax to: 800-535-7923; forward a copy of the letter to any institutions they may have forwarded the product and for customers using the GXXXXX64 kit that includes the Disposable General Purpose 9 French Temperature Probe follow the directions listed in the letter. Note: VSD is removing p/n 1016 and 1016EU, Disposable General Purpose 9 French Temperature Probe, from the market and offering a replacement. If you have any questions or concerns regarding this notification, contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation 8:00 am EST to 6:00 pm EST.
Quantity in commerce: 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.
Product codes and lots: Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers: 12089A 12131A 5575A 5586X 5633U 5664E 5685G 5712T 12090B 12138A 5578K 5603R 5636Y 5666R 5685H 5714Z 12100A 12157B 5578L 5606U 5638P 5668N 5685J 12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y 12102A 5573Q 5580Z 5615N 5648T 5669H 5691T 12108B 5574A 5581A 5621U 5648U 5671D 5692H 12109B 5574B 5581L 5623H 5653Z 5673V 5696Q 12114B 5574X 5583E 5631C 5658D 5683V 5700J 12117B 5574Y 5584C 5632V 5660C 5683W 5703N 12130B 5574Z 5584D 5633T 5664D 5683X 5708R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0407-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0407-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code KAK

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)