Z-0400-2019Class II

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

Name: Z-0400-2019 Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Creator: Safe N Simple, LLC
Published: 2018-08-22
License: https://open.fda.gov/license/

Safe N Simple, LLC / initiated 2018-08-22 / Terminated / root cause: manufacturing process

FDA source

Safe N Simple, LLC began a recall of Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315 on 2018-08-22. FDA classified it as Class II and gives the reason as "The sterilization process used was unqualified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0400-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-22
Posted: 2018-11-07
Terminated: 2020-03-17
Recalling firm: Safe N Simple, LLC
Product: Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Product code: NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Reason for recall: The sterilization process used was unqualified.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Safe n Simple extended the recall to the only customer that ordered the product in the lot numbers (see table). The firm provided a written notice to the customer mentioned in the table with specific instructions along with a phone conversation. Safe n Simple instructed the customer to provide the inventory level of SNS58315 and SNS58345 specific to lot numbers 18060564 and 18060563 respectively and to return such product to Safe N Simple LLC at Safe N Simple LLC expense. The effectiveness of the recall was good since the customer immediately responded by shipping all their inventory back to us.
Quantity in commerce: 104 cases
Distribution: CA
Product codes and lots: lot number 18060563

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0400-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0400-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07
Z-0401-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07

Product code NAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)