Recall Z-1467-2022— Covidien Llc
Class II · Ongoing
Class II FDA medical device recall by Covidien Llc, initiated 2022-06-07. It names 2 FDA 510(k) clearances: K132015, K031787. Product: TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808. 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..
- Recalling firm
- Covidien Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-07
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K132015 — TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
- K031787 — SMITH & NEPHEW IUR MORCELLATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.