Events

Recall of Sure Temp Plus Model 690/692 Oral Temperature Probes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Welch Allyn Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28030
  • Event Risk Class
    Class 2
  • Event Number
    Z-0354-04
  • Event Initiated Date
    2003-12-30
  • Event Date Posted
    2004-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31069
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thermometer, Electronic, Clinical - Product Code FLL
  • Reason
    Mechanical setting errors that result in calibration errors.
  • Action
    Recall letters dated 12/29/2003 were sent to all customers requesting quarantine and subrecall if needed. Consignees are to request return authorization for replacement.

Device

Sure Temp Plus Model 690/692 Oral Temperature Probes
  • Model / Serial
    Welch Allyn¿ Part #s: 0690-XXX Serial Numbers/Lot Numbers 02692-000 Oral Probe 4 ft. 412003-442003, 472003, 522003-582003. 02692-100 Oral Probe 9 ft. 412003-442003, 472003, 522003-582003 02893-000 Oral Probe Well Kit 4 ft. 412003-442003, 472003, 522003-582003 02893-100 Oral Probe Well Kit 9 ft. 412003-442003, 472003, 522003-582003    Probes are contained in Welch Allyn¿ Thermometer Boxes with Part #s: 0690-XXX Serial Numbers/Lot Numbers 01690-000 03397655 - 03505486 01690-200 03397655 - 03505486 E-01690-200 03397655 - 03505486 01690-300 03397655 - 03505486 01690-400 03397655 - 03505486 01690-410 03397655 - 03505486 01690-500 03397655 - 03505486 E-01692-200 03397655 - 03505486 01692-200 03397655 - 03505486 01692-300 03397655 - 03505486 01692-400 03397655 - 03505486 01692-500 03397655 - 03505486 01692-700 03397655 - 03505486    Probes are contained in Welch Allyn¿ Vital Signs Monitor III boxes with Part#s: Serial Numbers/Lot Numbers 53NTO-E1 JA000244, JA000282, JA000283, JA000284,  JA000285, JA000286, JA000287, JA000288, JA000289, JA000290, JA000291, JA000292, JA000293, JA000294, JA000295, JA000296, JA000297, JA000298, JA000299, JA000300, JA000301, JA000302, JA000303, JA000304, JA000305, JA000306, JA000307, JA000308, JA000309, JA000310, JA000311, JA000312, JA000313, JA000314, JA000315, JA000316, JA000317, JA000318, JA000319, JA000320, JA000331, JA000332, JA000333, JA000334, JA000335, JA000336, JA000337, JA000340, JA000341, JA000342, JA000343, JA000344, JA000345, JA000347, JA000348, JA000349, JA000352, JA000353, JA000354 53NTP-E1 JA000232, JA000243, JA000246, JA000255, JA000258, JA000259, JA000271, JA000278, JA000281, JA000326, JA000327, JA000328, JA000357
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Sure Temp Plus Model 690/692 Oral Temperature Probes
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc
  • Manufacturer Address
    Welch Allyn Inc, 7420 Carroll Rd, San Diego CA 92121-2334
  • Source
    USFDA