Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects
Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.
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: The recall involves a risk-of-harm product (infection from non-sterile equipment) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the B-V443Q-A 3-Lumen Extraction Balloon V, a medical device used with endoscopes to remove stones from the pancreatic and common bile ducts. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The devices were distributed nationwide in the US.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. If non-sterile equipment is used, patients may develop infections.
Healthcare providers and consumers should stop using the affected devices immediately. The affected lot codes are 06V, 07V, 08V, 09V, and 0XV. Users should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
- Manufacturer
- Aomori Olympus Co., Ltd.
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 (5)
- 06V
- 07V
- 08V
- 09V
- 0XV
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 111 recalled by Aomori Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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