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Terminated

Endotine Transbleph 3.5 (CFD-080-0167)

FDA Recall Z-2294-2016 · Posted None

Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2016-05-06
Date Terminated2016-08-12
Product Quantity29

Reason for Recall

MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

Firm Action

The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.

Root Cause

Labeling Change Control

Distribution Pattern

The product was distributed in the United States and Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042796ENDOTINE TRANSBLEPH 3.0/3.5 DEVICECoapt Systems, Inc. · 2004-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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