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Recall Observatory FDA recall evidence

Device 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.

Z-2369-2020

May 04, 2020

Class II

Product summary

Firm
Resource Optimization & Innovation LLC
Event
Event 85632
Status
Terminated
Classification
Class II
Quantity
12,640 units
Official record key
device-enforcement:Z-2369-2020

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 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.