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U.S. Department of Health and Human Services

Class 2 Device Recall Simpurity DermaPro Waterproof Silicone Tape, Safe'n'Simple, WOUNDCARE

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 Class 2 Device Recall Simpurity DermaPro Waterproof Silicone Tape, Safe'n'Simple, WOUNDCAREsee related information
Date Initiated by FirmDecember 14, 2017
Create DateJune 15, 2018
Recall Status1 Terminated 3 on April 04, 2019
Recall NumberZ-2229-2018
Recall Event ID 80234
Product Classification Tape and bandage, adhesive - Product Code KGX
ProductDermaPro Waterproof Silicone Tape, SNS57232
Code Information 20170716.
FEI Number 3008374791
Recalling Firm/
Manufacturer		 Safe N Simple, LLC
5827 Terex
Clarkston MI 48346-1717
For Additional Information ContactMr. Anthony T. Sajan
248-875-0840
Manufacturer Reason
for Recall		The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce318 rolls
DistributionDistributors in two states: AL and OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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