Recall Z-0026-2009
Applied Medical Resources Corp · initiated June 25, 2008
Product
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Codes / lots: Product/Kit Batch Numbers: 1060178, 1056644, 1056045
Reason for recall
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).
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0026-2009
- Initiated
- June 25, 2008
- Posted by FDA
- October 7, 2008
- Terminated
- March 26, 2012
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Quantity
- 14,113 total
- Distribution
- Nationwide and Canada distribution.
- Recalling firm
- Applied Medical Resources Corp, Rancho Santa Margarita, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0023-2009 | Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | 06/25/2008Terminated |
| Z-0024-2009 | Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | 06/25/2008Terminated |
| Z-0025-2009 | Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | 06/25/2008Terminated |
| Z-0027-2009 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | 06/25/2008Terminated |
| Z-0028-2009 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | 06/25/2008Terminated |
| Z-0029-2009 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii…Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric… | 06/25/2008Terminated |