Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
Lot Codes / Batch Numbers
Product/Kit Batch Numbers: 1059636, 1060354, 1061309, 1062314
Products Sold
Product/Kit Batch Numbers: 1059636, 1060354, 1061309, 1062314
Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa is recalling Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access Sy due to Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stret. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026