TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Covidien Llc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: AZ, CA, CO, IL, KS, MA, MI, MN, MO, NY, OK, PA, TN, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1467-2022
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