Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 13, 2016
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.
Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unab…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
AngioDynamics Inc. recalled NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN … - a moderate-severity action.
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN … was recalled by AngioDynamics Inc. in April 13, 2016. Reason: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specif…. Check the official notice for the remedy. Verify recall #Z-1346-2016 with the FDA Devices before acting.
The recall
AngioDynamics Inc. issued this moderate-severity FDA Devices recall-Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specif….
- Moderate
- severity level
- Class II
- classification
- April 13, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1346-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1346-2016) was formally reported on April 13, 2016, with the manufacturer initiating the action on November 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. AngioDynamics Inc. is listed as the recalling firm, operating out of Glens Falls, NY. Federal records list the affected scope as 45 kits.
The documented reason for this recall is: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as inten… Distribution data in the federal record shows the product reached: US Nationwide in the states of CA, IL, MA, SC, TX. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
45 kits
Related Recalls
6
3 from same agency
Product description
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.
Reason for recall
Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1346-2016 |
| Date reported | April 13, 2016 |
| Date initiated | November 3, 2015 |
| Recalling firm | AngioDynamics Inc. |
| Firm location | Glens Falls, NY |
| Affected scope | 45 kits |
| Distribution | US Nationwide in the states of CA, IL, MA, SC, TX |
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-1346-2016) 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? ▼
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.. Recalled by AngioDynamics Inc.. Units affected: 45 kits.
Why was this product recalled? ▼
Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1346-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of CA, IL, MA, SC, TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1346-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 13, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.