Recall Z-0534-2013— Arobella Medical, LLC

Name: FDA recall Z-0534-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-05

Class II · Terminated

Class II FDA medical device recall by Arobella Medical, LLC, initiated 2012-11-05, terminated 2015-03-04. It names one FDA 510(k) clearance: K062544. Product: Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.. Reason: This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System..

Recalling firm: Arobella Medical, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Terminated: 2015-03-04
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K062544 — AR1000 ULTRASONIC WOUND THERAPY SYSTEMArobella Medical, LLC·cleared 2007-01-03

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

Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

Reason for recall

This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.

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