Z-2330-2018Class II

Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

Name: Z-2330-2018 Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Creator: Safe N Simple, LLC
Published: 2012-06-18
License: https://open.fda.gov/license/

Safe N Simple, LLC / initiated 2012-06-18 / Terminated / root cause: manufacturing process

FDA source

Safe N Simple, LLC began a recall of Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 on 2012-06-18. FDA classified it as Class II and gives the reason as "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". 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-2330-2018
Classification: Class II
Status: Terminated
Initiated: 2012-06-18
Posted: 2018-06-29
Terminated: 2020-05-28
Recalling firm: Safe N Simple, LLC
Product: Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Product code: NEC Bandage, Liquid, Skin Protectant
Reason for recall: 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 tag: manufacturing process
FDA 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, [email protected]. 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 in commerce: 17592
Distribution: Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Product codes and lots: 20120115.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2330-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2330-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28

Product code NEC

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)