Recall Z-1131-2018 ยท KNG Monitor, Ultrasonic, Fetal
CooperSurgical, Inc.
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.
| Date | Oct 6, 2017 |
| Status | Terminated |
| Reason | The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe |
| Root cause | Error in labeling |
| Action | CooperSurgical sent an Urgent Medical Device Recall letter dated October 6, 2017 to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for replacement. If you have any further questions please feel free to contact me at 203.601.5200. |
| Quantity | 13 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of ( Canada and England) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024197 | LIFEDOP DOPPLER Summit Doppler Systems, Inc., Jan 3, 2003 |