Recall Z-2368-2020— Resource Optimization & Innovation LLC
Class II · Terminated
Class II FDA medical device recall by Resource Optimization & Innovation LLC, initiated 2020-05-04, terminated 2022-09-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field..
- Recalling firm
- Resource Optimization & Innovation LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-04
- Terminated
- 2022-09-23
- Firm location
- Saint Louis, MO, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.