Z-0026-2009

Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with...

Name: Z-0026-2009 Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with...
Creator: Applied Medical Resources Corp
Published: 2008-06-25
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2008-06-25 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures on 2008-06-25. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0026-2009
Status: Terminated
Initiated: 2008-06-25
Posted: 2008-10-07
Terminated: 2012-03-26
Recalling firm: Applied Medical Resources Corp
Product: Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Product code: HET Laparoscope, Gynecologic (And Accessories)
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).
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 14,113 total
Distribution: Nationwide and Canada distribution.
Product codes and lots: Product/Kit Batch Numbers: 1060178, 1056644, 1056045

Product code HET

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)