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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.…
- 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
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