FDA Medical Device Recalls (openFDA)
Safe N Simple, LLC: Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
- Recall number
- Z-2330-2018
- Recalling firm
- Safe N Simple, LLC
- Product
- Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
- Status
- Terminated
- Initiated
- 2012-06-18
- Posted
- not on file
- Terminated
- 2020-05-28
- Reason
- The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.
- Root cause
- Process design
- Action
- On June 18, 2012, the firm disseminated "Important-Action Required" recall information to affected distributors via email or phone call. The notification requested all distributors to immediately stop selling the product. The following instructions were provided: 1. Quantity on hand should be emailed to safen'simple customer service manager, Michelle Bliszack, mbliszack@snsmedicalwipes.com. We would like to know the current quantity you have in inventory of the subject product by Tuesday, June 19th, 2012. 2. We request the product with lot number 20120115 be either discarded or returned back to safen'simple. We will arrange and pay for shipment back to our warehouse. safen'simple will replace all existing stock of lot number 20120115 at no charge with a new lot number. 3. Until we ship replacement product, appropriate substitutes in performance are products SNS80725 and SNS80744. They are both similar product, however the size of the wipe is smaller. Packaging is 25 wipes/box and 100 wipes/box respectively.
- Quantity
- 17592
- Distribution
- Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
- Lot, serial or model codes
- 20120115.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEC
- 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