Class 2 Device Recall Grasper/Retriever, Alligator Jaw

• Date Initiated by Firm: January 12, 2021
• Create Date: August 06, 2021
• Recall Status: Completed
• Recall Number: Z-2229-2021
• Recall Event ID: 88136
• 510(K)Number: K974300
• Product Classification: Endoscopic grasping/cutting instrument, non-powered - Product Code OCZ
• 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
• Code Information: Lot Code: 020377208
• Recalling Firm/ Manufacturer: Shent USA, Inc.; 8 Kane Industrial Dr; Hudson MA 01749-2906
• For Additional Information Contact: Florencia Trevino; 978-567-9033
• Manufacturer 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).
• FDA Determined Cause: Packaging process control
• Action: Telemed issued Urgent Medical Device Recall letter on 1/12/21. Letter states reason for recall, health risk and action to take: Please respond to this recall notification (email response is acceptable) to let us know whether or not you have any of the recalled product in your inventory. If you are in possession of any recalled devices, please provide the quantity, catalog number and lot number. All affected devices must be returned to TeleMed; upon receiving your response to this notification, TeleMed Customer Service will provide you with an RGA number for product return. If you have any questions regarding this medical device recall, please contact: prakash@telemedsystems.com. 508-723-6609; Customerservice@telemedsystems.com 978-567-9033
• Quantity in Commerce: 47 units (20 US; 27 OUS)
• Distribution: US Nationwide Distribution - CA, CO, MI Foreign: Australia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = OCZ