The Recall Desk
ModerateFDA (Devices)·Z-1787-2022·Announced 2022-10-05

Saline wound flush recalled due to temperature exposure affecting effectiveness

Mckesson is recalling SafeWash Saline Wound Flush due to temperature exposure that may have reduced product effectiveness. The recall affects units distributed nationwide from June through September 2021.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall for temperature-induced potential loss of product effectiveness. No illnesses, injuries, or fatalities are reported. The source explicitly states the deviation is not likely to cause adverse health consequences, making this a precautionary measure with no demonstrated harm.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling SafeWash Saline Wound Flush (7.1 oz sterile saline solution, Model 00245). The recall is due to temperature excursions that occurred from June through August 2021 prior to product delivery. Exposure to higher temperatures may have impacted the product's effectiveness.

The affected product includes all lots received between June 1 and September 30, 2021. Approximately 375 units were distributed nationwide in the United States.

The FDA notes that this device with this specific storage temperature deviation is not likely to cause adverse health consequences.

The recalled product

Product
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-exposure
  • reduced-efficacy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • GTIN: 00714196245076 (EA)
  • 10714196245073 (CS)

Distribution

Distributed nationwide across the United States.