Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 32324159, Model # 4170.801
- 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:
- Richard Wolf GmbH
- Reason for Recall:
- Tube material of a smaller diameter was used.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
Product Codes/Lot Numbers:
Lot Number 32324159, Model # 4170.801
Distribution:
Distributed in: AT, CA, DE, DK, ES, FR, GB, HK, IS, LT, NO, NZ, SE, NL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2706-2020
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