DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
Check against the official notice below — it lists the full affected range.
Mckesson Medical-Surgical Inc. is recalling SafeWash Saline Wound Flush (7.1 oz. sterile 0.9% sodium chloride) due to facility temperature excursions that occurred between June and August 2021 prior to product delivery. The affected products are all lots received between June 1, 2021 and September 30, 2021. Exposure to higher temperatures during storage may have impacted the product's effectiveness. Approximately 375 units were distributed nationwide. The manufacturer states that this device with the specific storage temperature deviation is not likely to cause adverse health consequences.
The source document does not specify a remedy or recommended action for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 375 Lot/code info: GTIN: 00714196245076 (EA); 10714196245073 (CS)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.