FDAClass IINovember 14, 2018

Simpurity Hydrogel Absorbent Sheet Wound Dressing recall

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

Why was Simpurity Hydrogel Absorbent Sheet Wound Dressing recalled?

The sterilization process used was unqualified.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot number 18060563

Product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Recalling firm
Safe N Simple, LLC
Quantity
104 cases
Distribution
CA
Recall date
November 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls