Safe N Simple, LLC: Medical Device Recall in 2018 - (Recall #: Z-0400-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 22, 2018

Date Posted: November 14, 2018

Recall Number: Z-0400-2019

Event ID: 81150

Reason for Recall:

The sterilization process used was unqualified.

Status: Terminated

Product Quantity: 104 cases

Code Information:

lot number 18060563

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated