FDA Medical Device Recalls (openFDA)
Safe N Simple, LLC: Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
- Recall number
- Z-0401-2019
- Recalling firm
- Safe N Simple, LLC
- Product
- Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
- Status
- Terminated
- Initiated
- 2018-08-22
- Posted
- not on file
- Terminated
- 2020-03-17
- Reason
- The sterilization process used was unqualified.
- 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
- 125 cases
- Distribution
- CA
- Lot, serial or model codes
- lot number 18060564
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAE
- Firm FEI
- 3008374791
- Firm city
- Clarkston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28