Class 2 Device Recall VITALTEMP General Purpose Probe

• Date Initiated by Firm: August 17, 2012
• Date Posted: November 20, 2012
• Recall Status: Terminated on June 14, 2013
• Recall Number: Z-0407-2013
• Recall Event ID: 63532
• 510(K)Number: K925791 K944949 K822277
• Product Classification: Probe, ent - Product Code KAK
• Product: Vital Signs Disposable General Purpose 9 French Temperature Probe; For monitoring of core temperature
• Code Information: 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
• Recalling Firm/ Manufacturer: Vital Signs Colorado Inc.; 11039 East Lansing Circle; Englewood CO 80112-5909
• For Additional Information Contact: Ms. Gwen Braeger; 262-548-2608
• Manufacturer Reason for Recall: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KAK and Original Applicant = DEROYAL INDUSTRIES, INC.; 510(K)s with Product Code = KAK and Original Applicant = KELLEHER CORP.; 510(K)s with Product Code = KAK and Original Applicant = VITAL SIGNS, INC.