Micro-Tech Trident Endoscopic Ultrasonic Biopsy Needle Recall
Micro-Tech is recalling 40 Trident Endoscopic Ultrasonic Biopsy Needles because they may break in the human body, potentially causing injury.
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 medical device with a risk of injury due to breakage in the body, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Micro-Tech (Nanjing) Co., Ltd. is recalling 40 units of the Trident Endoscopic Ultrasonic Biopsy Needle (FNB). The recall involves product with identifier EUS-22-1-N, UPN ES34591, and M171226171. The affected products were distributed in the United States to one distributor in Michigan.
The recall is being issued because the needle may break in the human body. The firmness of the mass being biopsied, the position of the endoscope and elevator, and the force required to penetrate the mass may contribute to this breakage, which could cause injury.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
- Affected units
- 40
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 (1)
- Identifier EUS-22-1-N UPN ES34591 M171226171
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Micro-Tech (Nanjing) 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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