—#163165

Product

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 product code: MQG — Accessory, Assisted Reproduction
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K160753, K992070
Affected lot / code info: All lots

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.

Timeline

Recall initiated: 2018-03-22
Terminated: 2020-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.