Recall Z-2226-2009 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.
| Date | Sep 18, 2009 (initiated Jun 4, 2009) |
| Status | Terminated |
| Reason | Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage. |
| Root cause | Component design/selection |
| Action | Applied Medical Resources Corp. notified Customers via an overnight "Voluntary Recall Notification" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369). |
| Quantity | 934 units |
| Distribution | Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060096 | MODULAR TROCAR SYSTEM Applied Medical Resources Corp., Jan 24, 2006 |