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Recall Observatory FDA recall evidence

Device product

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

Z-2230-2021

January 12, 2021

Class II

Product summary

Firm
Shent USA, Inc.
Event
Event 88136
Status
Completed
Classification
Class II
Quantity
85 units OUS
Official record key
device-enforcement:Z-2230-2021

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: D20177226-19

Distribution pattern: US Nationwide Distribution - CA, CO, MI Foreign: Australia

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled