Home / Recalls / Welch Allyn Inc / Z-2482-2021

Z-2482-2021 Class II Ongoing

Recalled by Welch Allyn Inc — Skaneateles Falls, NY

Recall Details

Product Type
Devices
Report Date
September 22, 2021
Initiation Date
July 20, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,036,740 units

Product Description

Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000

Reason for Recall

If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Andorra, Australia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Canada, Chile, China, Colombia, Congo, Costa Rica, C¿te D'ivoire (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., Ecuador, Estonia, Finland, France, Frenc.Polynesia, French, Guiana, Germany, Greece, Guadeloupe, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Monaco, Myanmar, N.Mariana Islnd, Netherlands (the), New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Utd.Arab Emir., Vietnam, Zimbabwe.

Code Information

All Devices in distribution. UDI: 00732094309027 DDDYYKXXXXX DDD = 3 DIGIT JULIAN DAY (EXAMPLE - 234). YY = LAST 2 DIGITS OF JULIAN YEAR (EXAMPLE - 13) K = KEYTRONIC XXXXX = 5 DIGIT BASE 10 SERIALIZED NUMBER.

Other recalls by Welch Allyn Inc

  • Z-1673-2021 Class II — ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount mode (April 22, 2021)
  • Z-1672-2021 Class II — GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Tra (April 22, 2021)
  • Z-1777-2017 Class II — Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, (February 27, 2017)
  • Z-0169-2016 Class II — Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting Syst (October 2, 2015)