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.
FDA Recall Z-0029-2009 · Posted 2008-10-07
Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeGCJ
Date Initiated2008-06-25
Date Terminated2012-03-26
Product Quantity14,113 total
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).
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide and Canada distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.