FDA Medical Device Recalls (openFDA)
Stradis Medical, LLC dba Stradis Healthcare: Surgicare Neuro Pack - Neurological Kit
- Recall number
- Z-0862-2022
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Product
- Surgicare Neuro Pack - Neurological Kit
- Status
- Open, Classified
- Initiated
- 2022-02-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
- Root cause
- Process change control
- Action
- A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
- Quantity
- 176 units
- Distribution
- US Nationwide distribution in the states of IN, TX, and PA.
- Lot, serial or model codes
- SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJG
- 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