Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1989-2023 — Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A

U.S. FDA — Device Enforcement · United States · 2023-05-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1989-2023
Date of alert
2023-05-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170385933
Reported risk: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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