The Recall Desk
ModerateFDA (Devices)·Z-0955-2023·Announced 2023-01-18

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.

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: 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
Category
Medical Device — Ablation Catheter
Hazard
  • incorrect-expiration-date

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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