FDA Medical Device Recalls (openFDA)
Angiodynamics Inc. (Navilyst Medical Inc.): CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
- Recall number
- Z-2217-2018
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Product
- CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
- Status
- Terminated
- Initiated
- 2018-05-10
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- Root cause
- Material/Component Contamination
- Action
- Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
- Quantity
- 2 boxes
- Distribution
- The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
- Lot, serial or model codes
- UPN: H96560M7009361; Lot: 5316398.
- 510(k) numbers
- ["K163452"]
- PMA numbers
- not on file
- Product code
- LJS
- 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