ClearanceBrief
Recall Z-2229-2018 ยท KGX Tape And Bandage, Adhesive

Safe N Simple, LLC

DermaPro Waterproof Silicone Tape, SNS57232

DateDec 14, 2017
StatusTerminated
ReasonThe recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
Root causeProcess 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.
Quantity318 rolls
DistributionDistributors in two states: AL and OH.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.