—#181426

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.

FDA product code: PEZ — Central Venous Catheter Dressing Change Kit
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Resource Optimization & Innovation LLC
Address: 645 Maryville Centre Dr, Ste 200, Saint Louis, Missouri 63141-5846

Distribution

Distribution pattern: US Nationwide distribution including in the states of MO, NC.

Timeline

Recall initiated: 2020-05-04
Terminated: 2022-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181426. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.