Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip
Summary
The FDA issued a Class II for Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm by Olympus Corporation of the Americas. Reason: There have been complaints that the clip did not come out of the tube sheath during the procedure..
Details
Source
Device Recall
External ID
Z-1418-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
Product Description
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Lot/Code Info: 1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V
Quantity Affected: 65.9 boxes (373 pieces)
Reason for Recall
There have been complaints that the clip did not come out of the tube sheath during the procedure.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-23
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1418-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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