Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-401D-1321 aspiration needles because inspection found inadequate package 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 is classified as FDA Class II, and the hazard involves a risk of infection from non-sterile equipment, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NA-401D-1321 Aspiration Needle, model no. NA-401D-1321. This medical device is used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall involves 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 inspection confirmed that a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. The use of non-sterile equipment may result in patients developing infections.
Healthcare providers and facilities should stop using the affected aspiration needles and contact Aomori Olympus Co., Ltd. for instructions on return or replacement. The affected product codes are 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
The recalled product
- Product
- NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - 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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