Single Use Repositionable Clip QUICKCLIP PRO 165 CM recall
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Why was Single Use Repositionable Clip QUICKCLIP PRO 165 CM recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04953170385919 Lot Numbers: 24K, 27K, 29K, 2XK, 2YK
- Product
- Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 340 pieces
- Distribution
- US Nationwide distribution.
- Recall date
- June 28, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)