Recall Z-0926-2022 ยท FFL Dislodger, Stone, Basket, Ureteral, Metal
Philips North America, LLC
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.
| Date | Feb 7, 2022 |
| Status | Open, Classified |
| Reason | Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. |
| Root cause | Device Design |
| Action | 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 o |
| Quantity | 478,931 units |
| 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 Da |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE Yellow Springs Instrument Co., Inc., Jul 19, 1996 |