Recall Z-2294-2016— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-2294-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-06

Class II · Terminated

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2016-05-06, terminated 2016-08-12. It names one FDA 510(k) clearance: K042796. Product: Endotine Transbleph 3.5 (CFD-080-0167). Reason: 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)..

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-06
Terminated: 2016-08-12
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K042796 — ENDOTINE TRANSBLEPH 3.0/3.5 DEVICECoapt Systems, Inc.·cleared 2004-11-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endotine Transbleph 3.5 (CFD-080-0167)

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.