FDA Medical Device Recalls (openFDA)
Stradis Medical, LLC dba Stradis Healthcare: Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
- Recall number
- Z-0400-2022
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Product
- Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
- Status
- Terminated
- Initiated
- 2021-10-28
- Posted
- not on file
- Terminated
- 2023-08-07
- Reason
- This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
- Root cause
- Employee error
- Action
- Stradis Healthcare immediately contacted all 28 customers via email and/or phone between 10/28/21 and 10/29/21. The firm has requested the return of the units.
- Quantity
- 620 tube sets
- Distribution
- NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
- Lot, serial or model codes
- Lot code 20519-2103
- 510(k) numbers
- ["K993463"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1000111025
- Firm city
- Peachtree Corners
- Firm state
- GA
- 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