Reported Aug 25, 2021 · Terminated
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Oxygen
- Sensor Model K54019-2 used in theG185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153]
- Lot codes and dates
- Serial Numbers
430 of 430 codes
531540531541531542531543531544531545531546531547531548531549531550531551531552531553531554531555531556531557531558531559531560531561531562531563531564531565531566531567531568531569531570531571531572531573531574531575531576531577531578531579531580531581531582531583531584531585531586531587531588531589531590531591531597531598531599531600531601531602531603531604
- Serial Numbers
- Amount recalled
- 421 units
Where it was sold
Why it was recalled
Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.
This product could cause temporary or reversible health problems — stop using it.
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