Z-2369-2020Class II

Regard SRHS Central Line Kit, Sterile, 20/case -

Name: Z-2369-2020 Regard SRHS Central Line Kit, Sterile, 20/case -
Creator: Resource Optimization & Innovation LLC
Published: 2020-05-04
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2020-05-04 / Terminated / root cause: packaging

FDA source

Resource Optimization & Innovation LLC began a recall of 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... on 2020-05-04. FDA classified it as Class II and gives the reason as "There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2369-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-04
Posted: 2020-06-15
Terminated: 2022-09-23
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.
Product code: PEZ Central Venous Catheter Dressing Change Kit
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 12,640 units
Distribution: US Nationwide distribution including in the states of MO, NC.
Product codes and lots: Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2369-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2368-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15
Z-2369-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15

Product code PEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)