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.
FDA Recall Z-1461-2018 · Posted None
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Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeMQG
Date Initiated2018-03-22
Date Terminated2020-05-13
Product Quantity2,267
Reason for Recall
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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