Aomori Olympus Recalls PR-V614M 2-Lumen Cannulas Due to Seal Defects
Aomori Olympus is recalling PR-V614M 2-Lumen Cannulas because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the PR-V614M 2-Lumen Cannula, model no. PR-V614M. These medical devices are used with endoscopes to inject contrast medium in the biliary or pancreatic duct. The recall affects 260,395 units distributed nationwide in the United States, with a global total of 7,400,000 units.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
Healthcare providers and facilities should stop using the affected cannulas and contact Aomori Olympus Co., Ltd. for further instructions on the recall process.
The recalled product
- Product
- PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
- 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 (15)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
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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