Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-411D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is 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 infection from non-sterile equipment, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NA-411D-1521 Aspiration Needle, model no. NA-411D-1521. This medical device is used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall affects 260,395 units in the United States, with a global total of 7,400,000 units. The affected products were distributed nationwide in the US.
The recall was initiated after inspections confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment presents a risk that patients may develop infections.
Healthcare providers and consumers should stop using the affected aspiration needles immediately. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their medical supply provider for guidance on handling the recalled items.
The recalled product
- Product
- NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the 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 (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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