Aomori Olympus Recalls B7-2LA Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2LA Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
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 in the source text, fitting the criteria for a High severity score.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling B7-2LA Balloon Catheters (model no. B7-2LA) due to a defect in the sterile packaging. The product is used with endoscopes for the injection of contrast medium or other medical fluids into the biliary or pancreatic tract.
Inspection confirmed that a small percentage of the sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment poses a risk that patients may develop infections.
The recall affects 260,395 units distributed nationwide in the United States. Affected lot codes include 01K, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK. Healthcare providers and consumers should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
- 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 (9)
- 01K
- 02K
- 03K
- 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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