Device 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.
Z-2368-2020
Product summary
- Event
- Event 85632
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,360 units
- Official record key
device-enforcement:Z-2368-2020
Official wording
Reason: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Code information: Item number 303394REG: lot numbers: 259427, 262441, 264440, 268589, 268915, 271008, and 269694.
Distribution pattern: US Nationwide distribution including in the states of MO, NC.
Derived failure modes
-
Unknown
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.