NIPRO SafeTouch II Safety AVF Needle Recall for Torn Wings
Nipro Medical Corporation is recalling 160,000 NIPRO SafeTouch II Safety AVF Needles because the device has the potential to have torn wings.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Nipro Medical Corporation is recalling 160,000 units of the NIPRO SafeTouch II Safety AVF Needle, 17G x 1 1/2 inch (Item code FS+173230BC). The recall involves specific lots, identified as Lot #14A22 and Lot #14A26.
The recall was initiated because the device has the potential to have torn wings. This is a Class III recall, which indicates that the use of or exposure to the device is not likely to cause adverse health consequences.
The affected products were distributed in the United States, including Tennessee. Healthcare providers and facilities should stop using the affected needles and contact the manufacturer for further instructions.
The recalled product
- Product
- NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
- Manufacturer
- Nipro Medical Corporation
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 160,000
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 (2)
- Model No.: FS+173230BC
- Lot #14A22 and Lot #14A26.
Distribution
Distributed in 1 state:
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