Device product
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope
Z-2229-2021
Product summary
- Firm
- Shent USA, Inc.
- Event
- Event 88136
- Status
- Completed
- Classification
- Class II
- Quantity
- 47 units (20 US; 27 OUS)
- Official record key
device-enforcement:Z-2229-2021
Official wording
Reason: 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).
Code information: Lot Code: 020377208
Distribution pattern: US Nationwide Distribution - CA, CO, MI Foreign: Australia
Derived failure modes
-
Labeling or packaging
Mislabeled