Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 14, 2016
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measur…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Angiodynamics Inc. (Navilyst Medical Inc.) recalled Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The … - a moderate-severity action.
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The … was recalled by Angiodynamics Inc. (Navilyst Medical Inc.) in December 14, 2016. Reason: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label stat…. Check the official notice for the remedy. Verify recall #Z-0715-2017 with the FDA Devices before acting.
The recall
Angiodynamics Inc. (Navilyst Medical Inc.) issued this moderate-severity FDA Devices recall-There is a potential for stylet stiffening that is not accurately represented on the labeling. The label stat….
- Moderate
- severity level
- Class II
- classification
- December 14, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0715-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0715-2017) was formally reported on December 14, 2016, with the manufacturer initiating the action on June 8, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Angiodynamics Inc. (Navilyst Medical Inc.) is listed as the recalling firm, operating out of Glens Falls, NY. Federal records list the affected scope as 50 cartons (boxes of 5).
The documented reason for this recall is: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may cont… Distribution data in the federal record shows the product reached: Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & 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
50 cartons (boxes of 5)
Related Recalls
6
3 from same agency
Product description
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
Reason for recall
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0715-2017 |
| Date reported | December 14, 2016 |
| Date initiated | June 8, 2016 |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Firm location | Glens Falls, NY |
| Affected scope | 50 cartons (boxes of 5) |
| Distribution | Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & 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-0715-2017) 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? ▼
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 50 cartons (boxes of 5).
Why was this product recalled? ▼
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0715-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0715-2017) 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 December 14, 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.