FDA Medical Device Recalls (openFDA)
Resource Optimization & Innovation LLC: Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
- Recall number
- Z-2369-2020
- Recalling firm
- Resource Optimization & Innovation LLC
- Product
- Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
- Status
- Terminated
- Initiated
- 2020-05-04
- Posted
- not on file
- Terminated
- 2022-09-23
- Reason
- There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
- Root cause
- Under Investigation by firm
- Action
- The firm's supplier mailed an Urgent: Field Action Notification dated 04/21/2020 The notification informs the customers to remove the affected product from inventory and place it in quarantine immediately. The notification included a label template for printing the appropriate warning label. The customers will affix the warning label on all affected kits affected by the notification in inventory. The label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Labels can be printed. The customers should send quantity and end user information request to the contact listed. The kits do NOT need to be returned and may be used. The letter states, an alternate saline flush solution should be used to accompany patient procedures until field action inventory is depleted. The notification states, if any of the affected products identified above were further distributed, to ensure all end-users are appropriately notified of the product recall. Recall Response Forms should be completed and returned as soon as possible even if customers have no current product inventory.
- Quantity
- 12,640 units
- Distribution
- US Nationwide distribution including in the states of MO, NC.
- Lot, serial or model codes
- Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PEZ
- Firm FEI
- 3004513970
- Firm city
- Saint Louis
- Firm state
- MO
- 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