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.
Reported: June 24, 2020 Initiated: May 4, 2020 #Z-2369-2020
Product Description
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.
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.
Details
- Recalling Firm
- Resource Optimization & Innovation LLC
- Units Affected
- 12,640 units
- Distribution
- US Nationwide distribution including in the states of MO, NC.
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Resource Optimization & Innovation LLC. Units affected: 12,640 units.
Why was this product recalled? ▼
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2369-2020.
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