Recall Z-1900-2009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Corporation
ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA
| Date | Aug 30, 2009 (initiated Aug 5, 2008) |
| Status | Terminated |
| Reason | Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility. |
| Root cause | Package design/selection |
| Action | Firm initiated this recall on August 5, 2008. Consignees were notified via letter asking them to contact consignees and delivered via courier. Distribution discontinued on July 9, 2008. |
| Quantity | 23,443 units (includes distribution of previously returned product) |
| Distribution | Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland, Singapore, Russian Federatin, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, South Africa, South Korea, Poland, Thailand, Jordan, Belgium, Finland, Portugal, Cyprus, Italy, UAE, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030551 | ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS Arthrocare Corp., Mar 7, 2003 |