Recall Z-1467-2022 ยท HIH Hysteroscope (And Accessories)
Covidien Llc
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
| Date | Jun 7, 2022 |
| Status | Open, Classified |
| Reason | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. |
| Root cause | Device Design |
| Action | Medtronic issued Urgent Medical Device Recall letter on 6/7/22 (Field Action #: FA1259) via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: "Identify and quarantine all affected product. The enclosed Customer Notification DetailReport includes affected product for your facility. " Return all affected product in your inventory to Medtronic. a. Product purchased directly from Medtronic: rs.covidienfeedbackcustomerservice@medtronic.com b. Product purchased through distribut |
| Quantity | 33 units |
| Distribution | AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain |
| FDA record | Open on fda.gov |