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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Vacuum Pump

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  Class 2 Device Recall Cook Vacuum Pump see related information
Date Initiated by Firm March 22, 2018
Create Date April 19, 2018
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-1460-2018
Recall Event ID 79713
510(K)Number K992070  
Product Classification Accessory, assisted reproduction - Product Code MQG
Product Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607.

Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
Code Information All lots
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
812-339-2235
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 132
Distribution Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQG and Original Applicant = COOK UROLOGICAL, INC.
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