[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1279-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Devices which did not undergo thermoforming could deform and lose performance.
The recalled product
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Model/Catalog Number: KD-VC411Q-0730
- Material REF: (1) N5391330
- (2) N5391310
- (3) N5777630
- UDI-DI: (1) 04953170399329
- (2) 04953170399329
- (3) 04953170399329
- All Lots with a valid expiration date
Distribution
Distributed nationwide across the United States.
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