Recall Z-0926-2022— Philips North America, LLC

Name: FDA recall Z-0926-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-07

Class II · Ongoing

Class II FDA medical device recall by Philips North America, LLC, initiated 2022-02-07. It names one FDA 510(k) clearance: K962070. 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.. Reason: Update to instructions for use regarding the cleaning and disinfection process for the reusable probes..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-02-07
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K962070 — YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBEYellow Springs Instrument Co., Inc.·cleared 1996-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.