FDA Medical Device Recalls (openFDA)
Angiodynamics Inc. (Navilyst Medical Inc.): NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
- Recall number
- Z-1853-2017
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Product
- NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
- Status
- Terminated
- Initiated
- 2017-01-13
- Posted
- 2017-03-29
- Terminated
- 2018-06-25
- Reason
- The product has the potential to be non-sterile as it was not packaged in accordance to specification.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 8 boxes/25 units
- Distribution
- CA, KY, MD, OR, VA, TX
- Lot, serial or model codes
- Lot Number: 5122528
- 510(k) numbers
- ["K852140"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3017892510
- Firm city
- Glens Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28