FDAFDA · Food and drugs·Recall number Z-2230-2021
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
Published August 18, 2021 · Recall initiated: January 12, 2021
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shent USA, Inc.
- Distributor
- US Nationwide Distribution - CA, CO, MI Foreign: Australia
- Lot
- Lot Code: D20177226-19
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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