Z-0955-2023 Class II Ongoing
FDA device recall Z-0955-2023 was initiated by Covidien, LLC on Nov 23, 2022 and is designated Class II. Reason for recall: The product is labeled with the incorrect expiration date. The recall status is ongoing. Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 18, 2023
- Initiation Date
- Nov 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Reason for Recall
The product is labeled with the incorrect expiration date.
Distribution Pattern
Foreign Distribution: Hong Kong
Code Information
UDI/DI (GTIN): 10884521825765, Lot Number: 520200
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0955-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026