FDA · Medical device recall

Regard SRHS GIC Port A Cath… and 1 more product

June 24, 2020 Class II

Date: June 24, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Resource Optimization & Innovation LLC
Reason: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Distribution pattern: US Nationwide distribution including in the states of MO, NC.

2 products in this recall

Regard SRHS GIC Port A Cath…

Product: Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Quantity: 9,360 units
Codes and lots: Item number 303394REG: lot numbers: 259427, 262441, 264440, 268589, 268915, 271008, and 269694.
Recall started: May 4, 2020
Device type: Central Venous Catheter Tray
Root cause (FDA): Under Investigation by firm
What the company told customers: 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.
Recall number: Z-2368-2020

Regard SRHS Central Line Kit…

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.
Quantity: 12,640 units
Codes and lots: Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.
Recall started: May 4, 2020
Device type: Central Venous Catheter Dressing Change Kit
Root cause (FDA): Under Investigation by firm
What the company told customers: 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.
Recall number: Z-2369-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2368-2020, Z-2369-2020. The agency record governs; check it and the company before acting.

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