Aomori Olympus Recalls B5-2C Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B5-2C balloon catheters 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 no specific injuries or illnesses have been reported yet, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the B5-2C Balloon Catheter 11MM DIA 2.0 (Model No. B5-2C). This medical device is used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. The recall affects 260,395 units distributed nationwide in the United States, with a global total of 7,400,000 units. Affected product codes include 01K, 02K, 03K, 04K, 05K, 06K, 07K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
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 can lead to patient infections.
Healthcare providers and facilities should stop using the affected catheters and contact Aomori Olympus Co., Ltd. for further instructions on the recall.
The recalled product
- Product
- B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
- 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 (13)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 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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