Wound Dressing Units Recalled Due to Storage Temperature Excursions
KerraCel Ag wound dressing units distributed between June and September 2021 are being recalled due to facility temperature excursions that may have affected product effectiveness. The FDA states no adverse health consequences are likely.
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: FDA Class III recall with no reported illnesses or injuries. The source explicitly states the product is not likely to cause adverse health consequences. The issue involves potential loss of product effectiveness from improper storage conditions rather than direct safety risk.
Plain-English summary
McKession Medical-Surgical Inc. is recalling KerraCel Ag wound dressing units (catalog #CWL1158), which were distributed nationwide in the United States.
The recall is due to facility temperature excursions that occurred between June and August 2021, prior to product delivery. Exposure to higher temperatures may have impacted the product's effectiveness. All lots with receipt dates between June 1, 2021 and September 30, 2021 are affected.
The FDA has determined that this device with this specific storage temperature deviation is not likely to cause adverse health consequences.
The recalled product
- Product
- 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Wound Dressing
- Hazard
- temperature-exposure
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 (3)
- GTIN: 05060077233539 EA
- 05060077233546 CA
- 05060077233553 CS
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03