COVIDIEN Emprint Ablation Catheter recalled for incorrect expiration date
COVIDIEN Emprint Ablation Catheters (Lot 520200) are recalled because they are labeled with an incorrect expiration date. The 21 affected units were distributed to Hong Kong.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 II medical device recall for a labeling error—specifically, incorrect expiration date. No injuries, illnesses, or deaths have been reported. Per the severity rubric, minor labeling errors are classified as Moderate (Score 2).
Plain-English summary
Covidien, LLC is recalling COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, model REF CA108L1, Lot 520200. The recall involves 21 units of this bronchoscopic ablation device.
The product is labeled with an incorrect expiration date.
The affected units were distributed outside the United States, specifically to Hong Kong.
The recalled product
- Product
- COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
- Manufacturer
- Covidien, LLC
- Affected units
- 21
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)
- UDI/DI (GTIN): 10884521825765
- Lot Number: 520200
Distribution
Distribution scope not specified by the agency.
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