Z-2226-2009

Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile...

Name: Z-2226-2009 Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile...
Creator: Applied Medical Resources Corp
Published: 2009-06-04
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2009-06-04 / Terminated / root cause: design

FDA source

Applied Medical Resources Corp began a recall of Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use... on 2009-06-04. The reason FDA records is "Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2226-2009
Status: Terminated
Initiated: 2009-06-04
Posted: 2009-09-18
Terminated: 2011-07-14
Recalling firm: Applied Medical Resources Corp
Product: Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
Root cause tag: design
FDA root cause: Component design/selection
Action: Applied Medical Resources Corp. notified Customers via an overnight "Voluntary Recall Notification" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).
Quantity in commerce: 934 units
Distribution: Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.
Product codes and lots: Model Number: C0R36, Lot Numbers:1084426 and 1085506.

Product code GCJ

K060096Class IIModular Trocar SystemApplied Medical Resources Corp. / cleared 2006-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)