The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.
Recall
- Recall Number
- Z-0926-2022
- Event Number
- 89791
- Firm
- Philips North America, LLC
- FEI Number
- 1218950
- Product Code
- FFL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- February 7, 2022
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
The firm, Philips, issued "URGENT Medical Device Recall" Customer notification letters on 07 Feb 2022 via certified mail. Actions planned by the firm: An IFU addendum (part# 453564978601) was created that provides updated instructions for cleaning, disinfection, and sterilization. This addendum is to be downloaded www.philips.com/ifu and kept with the main IFU (part# 453564635891). Customer should take the following actions to prevent risk to patients or users: Prepare and soak in an enzymatic solution (detergent) to remove any debris prior to disinfection or sterilization. To reduce risk of cross-infection always clean all probes before applying to a different patient. Esophageal/Rectal Probes must be cleaned and sterilized between patient use. Skin probes can be cleaned and disinfected or cleaned and sterilized between patient use. Contact Philips Customer Services with questions. US customers: 1 (800) 722-9377, Worldwide customers: Contact local Philips representative.
Worldwide distribution: US (nationwide) Including Puerto Rico and OUS (foreign) countries including: Afghanistan, Albania, Algeria, Angola, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burundi, Cambodia, Canada, Chile, China, Columbia, Congo (Democratic Republic of the), Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Japan, Jordan, Kazakhstan, Korea Republic of, Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives, Mali, Malta, Mauritius, Mayotte, Mexico, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Lucia, Saint Pierre and Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Swaziland, Sweden, Switzerland, Syrian and Republic, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen and Zambia.
478,931 units