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.
Check against the official notice below — it lists the full affected range.
Philips North America is recalling autoclavable temperature probes (Part # 453564635891) in models 21075A, 21076A, 21078A, 989803162621, 989803162631, and 989803162641 distributed worldwide, including throughout the United States and Puerto Rico. The recall affects approximately 478,931 units manufactured from 2008 to the present and involves an update to the instructions for use regarding the cleaning and disinfection process for these reusable probes.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Reason for recall: Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. Distribution: 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 Quantity: 478,931 units Lot/code info: All lots manufactured IFUs from 2008 to present. UDI for probe model 21075A (01)00884838000995, model 21076A (01)00884838001008, model 21078A (01)00884838001015, model 989803162621 (01)00884838008045, model 989803162631 (01)00884838008052, and model 989803162641 (01) 00884838008069
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.