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U.S. Department of Health and Human Services

Class 2 Device Recall VITALTEMP General Purpose Probe

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  Class 2 Device Recall VITALTEMP General Purpose Probe see related information
Date Initiated by Firm August 17, 2012
Date Posting Updated November 20, 2012
Recall Status1 Terminated 3 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 2
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.
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