Philips Autoclavable Temperature Probes: Updated Cleaning Instructions
Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a documentation update to the instructions for use with no reported illnesses or injuries. The recall is precautionary and relates to clarification of cleaning and disinfection procedures.
Plain-English summary
Philips North America, LLC is issuing an update to the instructions for use (IFU) for autoclavable temperature probes (Part #453564635891) in models 21075A, 21076A, 21078A, 989803162621, 989803162631, and 989803162641. The update addresses the cleaning and disinfection process for these reusable probes.
Approximately 478,931 units have been distributed worldwide, including throughout the United States (including Puerto Rico) and over 100 countries. All lots manufactured from 2008 to the present are affected.
Owners and users of these probes should review the updated instructions for cleaning and disinfection to ensure proper handling of the reusable probes. Contact Philips North America, LLC for the updated instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Philips North America, LLC
- Affected units
- 478,931
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- model 21076A (01)00884838001008
- model 21078A (01)00884838001015
- model 989803162621 (01)00884838008045
- model 989803162631 (01)00884838008052
- and model 989803162641 (01) 00884838008069
Distribution
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