Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Recall
- Recall Number
- Z-1461-2018
- Event Number
- 79713
- Firm
- Cook Inc.
- FEI Number
- 1820334
- Product Code
- MQG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 22, 2018
- Terminated
- May 13, 2020
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120
Description
Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
An Urgent: Medical Device Correction letter, dated March 20, 2018, was sent to consignees. The letter identified the affected device and provided a description of the problem. The firm stated that it would be replacing the mains wiring for each unit. An authorized service agent will contact customers to arrange for the affected devices to be corrected. Customers are to follow the instructions regarding the residual current device (RCD) provided in the letter, while they are waiting for their devices to be corrected. Additionally, customers should complete the Acknowledgement and Receipt Form within 5 business days of receiving the letter. Questions or concerns should be directed to Cook Medical Capital Equipment Service at 855-207-7214.
Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
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