FDA Enforcement
Class II
Completed
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
Recall: Z-2230-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2230-2021
- Event ID
- 88136
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Shent USA, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 18, 2021
- Initiation Date
- January 12, 2021
- Classification Date
- August 6, 2021
- Address
- 8 Kane Industrial Dr, N/A, Hudson, MA, 01749-2906, United States
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
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 Info
Lot Code: D20177226-19
Distribution
US Nationwide Distribution - CA, CO, MI Foreign: Australia
Quantity
85 units OUS