CooperSurgical, Inc. recalls Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Wit…

Recall date

September 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0029-2020

FDA classification

Class III

Brand / firm

CooperSurgical, Inc.

Sold / distributed

Worldwide distribution - including US Nationwide in the states of CA, CO, CT, GA, IL, MI, NC, NJ, PA, & WA, and countries of Canada and Denmark.

Why it was recalled

The touchpad may not work properly after cleaning.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.