AquaGuard Wound Dressing Recall Due to Facility Temperature Excursions
TIDI Products AquaGuard wound dressings received June–September 2021 were exposed to elevated storage temperatures that may have impacted product effectiveness. The FDA states adverse health consequences are unlikely.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III device with no reported illnesses or injuries. FDA explicitly states the device is not likely to cause adverse health consequences despite temperature excursion prior to delivery.
Plain-English summary
TIDI Products, LLC AquaGuard DRESSING products are being recalled due to potential exposure to elevated temperatures during storage at the distribution facility prior to shipment. Between June 2021 and August 2021, temperature excursions in the facility may have impacted product effectiveness.
The recall affects two variants: AquaGuard Moisturizer 7x7 (5-pack) catalog number 68751510104, and AquaGuard Moisturizer Barrier 10x12 (5-box) catalog number 68751510105. All lots received between June 1, 2021, and September 30, 2021, are included in this recall. The products were distributed nationwide. The FDA states this device with this specific storage temperature deviation is not likely to cause adverse health consequences.
The recalled product
- Product
- a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Wound Dressing
- Hazard
- temperature-excursion
- product-degradation
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 (1)
- not available
Distribution
Distributed nationwide across the United States.
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