The Recall Desk
HighFDA (Devices)·Z-0534-2013·Announced 2012-12-26

Arobella Medical 6mm Qurette Recalled for Fracture Risk During Use

Arobella Medical is recalling 6mm Qurettes used in the AR1000 Wound Therapy System because they can fracture during use and release fragments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a component fracturing during use, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, placing it in the 'High' severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arobella Medical, LLC is recalling 99 units of the 6mm Qurette (Lot Numbers 0001 and 0002) used with the Arobella Medical AR1000 Wound Therapy System. The recall was initiated because the Qurettes can fracture during use and may release a fragment or fragments.

The 6mm Qurette is a component of the AR1000 Quostic Wound Therapy System, which is intended for the selective dissection and fragmentation of tissue, wound debridement, and cleansing irrigation of the wound site. The affected units were distributed worldwide, including nationwide in the United States and in Saudi Arabia.

Healthcare providers and consumers should stop using the affected Qurettes immediately. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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
Manufacturer
Arobella Medical, LLC
Category
Medical Device — Wound Therapy
Hazard
Affected units
99

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 0001 and 0002

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Related recalls

Same hazard · fracture

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