CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
Namic Fluid Delivery Set - 72" UPN H965913000051 recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Namic Fluid Delivery Set - 72" UPN H965913000051, distributed in California, Kentucky, Maryland, Oregon, Texas, Virginia. The recall was initiated on 13 Jan 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1853-2017
- FDA event ID
- 76347
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2017
- FDA classified
- 18 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Jan 2017 | Recall initiated by company | |
| 18 Apr 2017 | Classified by FDA | +95 days |
| 26 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Where it was distributed
CA, KY, MD, OR, VA, TX
Questions about this recall
Why was it recalled?
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
Which lots are affected?
Lot Number: 5122528
Where was it sold?
CA, KY, MD, OR, VA, TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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