Home / Recalls / Olympus Corporation of the Americas / Z-1988-2023

Z-1988-2023 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
June 28, 2023
Initiation Date
May 4, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 pieces

Product Description

Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI: 04953170385926 Lot Numbers: 24K, 26K, 27K, 29K, 2XK, 2YK

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