medical Class II Updated 2022-08-03

Covidien Llc recalls TruClear Hysteroscopic Tissue Removal System Control Unit- d

Recalled Product

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CO, IL, KS, MA, MI, MN, MO, NY, OK, PA, TN, TX, WA
Lot/Code Info: UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182
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