NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051… recallZ-1853-2017 · Angiodynamics Inc. (Navilyst Medical Inc.) · initiated Jan 13, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics Inc. (Navilyst Medical Inc.) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
FDA root cause category: Under Investigation by firm
What the company is doing
On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification.
Recall details
- Recall number
- Z-1853-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 13, 2017
- Posted by the FDA
- Mar 29, 2017
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Quantity
- 8 boxes/25 units
- Product code
- FPA
- FDA submissions
- K852140
- Distribution
- CA, KY, MD, OR, VA, TX
Product description
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Code information (models, lots, serial numbers)
Lot Number: 5122528
Other devices under the same FDA submission
1 device cleared under K852140 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NAMIC 64000935Navilyst Medical, Inc. · Set, administration, intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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