Recall Z-0029-2009 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
| Date | Oct 7, 2008 (initiated Jun 25, 2008) |
| Status | Terminated |
| Reason | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). |
| Root cause | Process control |
| Action | Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided. |
| Quantity | 14,113 total |
| Distribution | Nationwide and Canada distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012884 | DILATING TIP OBTURATOR Applied Medical Resources Corp., Jan 17, 2002 |