Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000
FDA device recall Z-0534-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- Arobella Medical, LLC
- 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.
- Action taken
- Arobella Medical sent an " Urgent: Medical Device Recall" letter dated November 2, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine and return any product subject to the recall. If the affected product have been further distributed, customers were advised to notify their customers of the product recall. For questions call 952-288-2810.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 99
- Distribution
- Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.
- Date initiated
- 2012-11-05
- Date posted
- 2012-12-17
- Date terminated
- 2015-03-04
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AR1000 ULTRASONIC WOUND THERAPY SYSTEM (K062544) | Arobella Medical, LLC | 2007-01-03 |