Z-2162-2013Class II

Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16...

Name: Z-2162-2013 Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16...
Creator: Medical Indicators, Inc.
Published: 2013-07-10
License: https://open.fda.gov/license/

Medical Indicators, Inc. / initiated 2013-07-10 / Terminated / root cause: labeling and UDI

FDA source

Medical Indicators, Inc. began a recall of 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... on 2013-07-10. FDA classified it as Class II and gives the reason as "TempaDot products may have been mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2162-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-10
Posted: 2013-09-06
Terminated: 2014-01-16
Recalling firm: Medical Indicators, Inc.
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.
Product code: FQZ Thermometer, Clinical Color Change
Reason for recall: TempaDot products may have been mislabeled.
Root cause tag: labeling and UDI
FDA root cause: 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: [email protected]. 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: [email protected], 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.
Product codes and lots: Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2162-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-06

Product code FQZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)