Z-2229-2018Class II

DermaPro Waterproof Silicone Tape, SNS57232

Name: Z-2229-2018 DermaPro Waterproof Silicone Tape, SNS57232
Creator: Safe N Simple, LLC
Published: 2017-12-14
License: https://open.fda.gov/license/

Safe N Simple, LLC / initiated 2017-12-14 / Terminated / root cause: manufacturing process

FDA source

Safe N Simple, LLC began a recall of DermaPro Waterproof Silicone Tape, SNS57232 on 2017-12-14. FDA classified it as Class II and gives the reason as "The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion". 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-2229-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-14
Posted: 2018-06-15
Terminated: 2019-04-04
Recalling firm: Safe N Simple, LLC
Product: DermaPro Waterproof Silicone Tape, SNS57232
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm notified its distributors via phone call and email on January 3, 2018. The firm informed distributors of the issue with the affected product, and offered to replace affected product, and suggested replacing product distributed to customers.
Quantity in commerce: 318 rolls
Distribution: Distributors in two states: AL and OH.
Product codes and lots: 20170716.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2229-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2229-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14

Product code KGX

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)