Skip to content
Recall Observatory FDA recall evidence

Device product

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

Z-0400-2019

August 22, 2018

Class II

Product summary

Firm
Safe N Simple, LLC
Event
Event 81150
Status
Terminated
Classification
Class II
Quantity
104 cases
Official record key
device-enforcement:Z-0400-2019

Official wording

Reason: The sterilization process used was unqualified.

Code information: lot number 18060563

Distribution pattern: CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sterilization process used was unqualified.