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Recall Observatory FDA recall evidence

Device product

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Z-0955-2023

November 23, 2022

Class II

Product summary

Firm
Covidien, LLC
Event
Event 91318
Status
Ongoing
Classification
Class II
Quantity
21 units
Official record key
device-enforcement:Z-0955-2023

Official wording

Reason: The product is labeled with the incorrect expiration date.

Code information: UDI/DI (GTIN): 10884521825765, Lot Number: 520200

Distribution pattern: Foreign Distribution: Hong Kong

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product is labeled with the incorrect expiration date.