Z-0027-2009

Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1)...

Name: Z-0027-2009 Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1)...
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, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System... 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-0027-2009
Status: Terminated
Initiated: 2008-06-25
Posted: 2008-10-07
Terminated: 2012-03-26
Recalling firm: Applied Medical Resources Corp
Product: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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: 1057269, 1057814, 1058172, 1058834, 1059466, 1059823, 1060637, 1061254, 1062450, 1062867, 1063561, 1063797, 1064872

Product code GCJ

K012884Class IIDilating Tip ObturatorApplied Medical Resources Corp. / cleared 2002-01-17

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)