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FDA Devices recall · Reported January 13, 2016

NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

Device has the potential to have torn wings.

Recall #
Z-0599-2016
Affected scope
160,000 pieces.
Initiated
April 1, 2014
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Nipro Medical Corporation recalled NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. - a low-severity action.

NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. was recalled by Nipro Medical Corporation in January 13, 2016. Reason: Device has the potential to have torn wings.. Check the official notice for the remedy. Verify recall #Z-0599-2016 with the FDA Devices before acting.

The recall

Nipro Medical Corporation issued this low-severity FDA Devices recall-Device has the potential to have torn wings..

Low
severity level
Class III
classification
January 13, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0599-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

Reason for recall

Device has the potential to have torn wings.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number Z-0599-2016
Date reported January 13, 2016
Date initiated April 1, 2014
Recalling firm Nipro Medical Corporation
Firm location Miami, FL
Affected scope 160,000 pieces.
Distribution US distribution including TN.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0599-2016) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.. Recalled by Nipro Medical Corporation. Units affected: 160,000 pieces..
Why was this product recalled?
Device has the potential to have torn wings.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 13, 2016. Severity: Low. Recall number: Z-0599-2016.
Where was the recalled product distributed?
Distribution: US distribution including TN..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Devices, reported January 13, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026