Temno Soft Tissue Biopsy Device Recalled for Temperature Exposure
Merit Medical Systems Temno soft tissue biopsy devices may have lost effectiveness due to storage temperature excursions between June and August 2021. The recall affects all lots received between June 1 and September 30, 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—temperature exposure may have affected device effectiveness—making this a precautionary recall.
Plain-English summary
Merit Medical Systems Temno soft tissue biopsy devices (Model T146) are being recalled due to potential loss of effectiveness caused by facility temperature excursions. The devices were exposed to higher-than-appropriate temperatures between June and August 2021 prior to delivery, which may have impacted their effectiveness.
This recall affects all lots received between June 1, 2021, and September 30, 2021. Eight boxes of the affected product were distributed nationwide in the United States.
Patients and healthcare providers who have these devices should contact the manufacturer (Mckesson Medical-Surgical Inc.) for information about replacement devices or further guidance.
The recalled product
- Product
- MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- reduced-effectiveness
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: 00884450444467
- 20884450444461
- 10884450444464
Distribution
Distributed nationwide across the United States.
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