Reported Oct 9, 2019 · Terminated

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

CooperSurgical, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B -
  • Product UsageRI 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 useProvide a favorable temperature environment for the embryo during the IVF procedure
Lot codes and dates
  • Serial Numbers

    606 of 606 codes

    • 0006
    • 0051
    • 0097
    • 0146
    • 0192
    • 0244
    • 0292
    • 0354
    • 0420
    • 0487
    • 0617
    • 0672
    • 0732
    • 0783
    • 0007
    • 0052
    • 0098
    • 0147
    • 0193
    • 0245
    • 0293
    • 0356
    • 0421
    • 0489
    • 0618
    • 0673
    • 0733
    • 0784
    • 0008
    • 0053
    • 0100
    • 0148
    • 0194
    • 0246
    • 0294
    • 0357
    • 0424
    • 0490
    • 0619
    • 0674
    • 0734
    • 0785
    • 0009
    • 0054
    • 0101
    • 0149
    • 0195
    • 0247
    • 0297
    • 0358
    • 0426
    • 0491
    • 0622
    • 0675
    • 0735
    • 0786
    • 0010
    • 0055
    • 0102
    • 0150
Amount recalled
60

Where it was sold

Why it was recalled

The touchpad may not work properly after cleaning.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 2, 2021 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.