Recall Z-0029-2020— CooperSurgical, Inc.

Name: FDA recall Z-0029-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-05

Class III · Terminated

Class III FDA medical device recall by CooperSurgical, Inc., initiated 2019-09-05, terminated 2021-09-02. It names one FDA 510(k) clearance: K160504. Product: 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.. Reason: The touchpad may not work properly after cleaning..

Recalling firm: CooperSurgical, Inc.
Classification: Class III
Status: Terminated
Initiated: 2019-09-05
Terminated: 2021-09-02
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K160504 — RI Witness Embryology Heated PlateResearch Instruments Limited·cleared 2016-07-18

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

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.

Reason for recall

The touchpad may not work properly after cleaning.

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