Recall Z-1460-2018 ยท MQG Accessory, Assisted Reproduction
Cook Inc.
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.
| Date | Mar 22, 2018 |
| Status | Terminated |
| Reason | 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 | 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 F |
| Quantity | 132 |
| Distribution | Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992070 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR Cook Urological, Inc., Oct 27, 1999 |