Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
This recall is currently active, issued June 21, 2023. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- May 4, 2023
- Posted
- June 21, 2023
- Recall Number
- Z-1990-2023
- Quantity
- 3795 pieces
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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
US Nationwide distribution.
Lot / Code Info
UDI-DI: 04953170385940 Lot Numbers: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK
Root Cause
Under Investigation by firm
Action Taken
Olympus issued Urgent Medical Device Recall Letter dated 5/4/23. Letter states reason for recall, health risk and action to take: 1. Immediately assess any product you have to identify HX-202LR/UR with affected lot number listed in this communication, cease use of product and quarantine any affected product. The images in Attachment 1 depict the area where the lot number is identified. The lot# is on the carton box, pack and handle. 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the recall number: 0424 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Contact (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.