Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
- Recall Initiated
- June 25, 2008
- Posted
- October 7, 2008
- Terminated
- March 26, 2012
- Recall Number
- Z-0027-2009
- Quantity
- 14,113 total
- Firm Location
- Margarita, CA
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).
Distribution
Nationwide and Canada distribution.
Lot / Code Info
Product/Kit Batch Numbers: 1057269, 1057814, 1058172, 1058834, 1059466, 1059823, 1060637, 1061254, 1062450, 1062867, 1063561, 1063797, 1064872
Root 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.