medical Class II Updated 2022-04-20

Philips North America, LLC recalls The IFU for the Autoclavable Temperature Probes: Part # 4535

Recalled 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.

Hazard / Issue

Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.

Issued by

FDA

Distribution: Nationwide (United States)

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

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