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Class 2 Device Recall Tempa DOT |
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Date Initiated by Firm |
July 10, 2013 |
Date Posted |
September 06, 2013 |
Recall Status1 |
Terminated 3 on January 16, 2014 |
Recall Number |
Z-2162-2013 |
Recall Event ID |
65905 |
Product Classification |
Thermometer, clinical color change - Product Code FQZ
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Product |
Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com
Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use. |
Code Information |
Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225 |
Recalling Firm/ Manufacturer |
Medical Indicators, Inc. 16 Thomas J. Rhodes Industrial Drive Hamilton NJ 08619
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For Additional Information Contact |
Mr. Paul A. Baker 609-737-1600 Ext. 204
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Manufacturer Reason for Recall |
TempaDot products may have been mislabeled.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The firm, Medical Indicators Inc.sent an "URGENT" Recall letter dated July 10, 2013 and Acknowledgement Form to all distributors/customers via email and Priority Mail with delivery confirmation. The letter described the product, problem and actions to be taken. The customers were instructed to check full & partial cases of the tempadot; open and inspect all 5122NS cases; pull out and quarantine any of the lots found in the 5122NS cases, pending return to medical indicators; if individual Tempadot 100-count boxes of 5122 and 5122NS are stored in different warehouse follow the instructions provided in the letter; if Tempadot 100-count boxes of 5122 were sold to a customer with the affected lots, contact the customer and have them return the product; and complete and return the Recall Return Response Acknowledgement and Receipt Form via mail to: 16 Thomas J Rhodes Industrial Drive, Hamilton NJ, 08619; fax: (609) 587-5636 or email to: www.medicalindicators.com or General Manager at: pbaker@medicalindicators.com.
Contact information for any question(s) related to this recall may be addressed to General Manager of Medical Indicators, Inc. at 609-737-1600, extension 204 or email to: pbaker@medicalindicators.com, Mondays through Fridays from 8:00am to 5:00pm EST. |
Quantity in Commerce |
111,800 boxes (5,590 full boxes) |
Distribution |
Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI. |
Total Product Life Cycle |
TPLC Device Report
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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.
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