Z-2230-2021 Class II

Recalled by Shent USA, Inc. — Hudson, MA

Recall Details

Product Type
Devices
Report Date
August 18, 2021
Initiation Date
January 12, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
85 units OUS

Product Description

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

Reason for Recall

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).

Distribution Pattern

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

Code Information

Lot Code: D20177226-19