FDAClass IIIOctober 5, 2022

DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush recall

DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245

Why was DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush recalled?

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

GTIN: 00714196245076 (EA); 10714196245073 (CS)

Product
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
375
Distribution
US Nationwide distribution.
Recall date
October 5, 2022
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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