Z-3005-2011

Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and inserts are indicated...

Name: Z-3005-2011 Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and inserts are indicated...
Creator: Applied Medical Resources Corp
Published: 2011-03-07
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2011-03-07 / Terminated / root cause: packaging

FDA source

Applied Medical Resources Corp began a recall of Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular... on 2011-03-07. The reason FDA records is "The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3005-2011
Status: Terminated
Initiated: 2011-03-07
Posted: 2011-08-11
Terminated: 2012-03-26
Recalling firm: Applied Medical Resources Corp
Product: Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.
Product code: DXC Clamp, Vascular
Reason for recall: The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier.
Root cause tag: packaging
FDA root cause: Other
Action: The firm, Applied Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 11, 2011 to its customers. The letter provides customers with an explanation of the problem identified and actions to be taken. The customers were instructed to check their inventory; complete and return the attached Voluntary Recall Notification Confirmation Form via fax to Regulatory Affairs at 949-713-8832, and return the recalled Standard 86mm Inserts immediately to Applied Medical, Attn: RGA# 60308783, 22872 Avenida Empresa, Rancho Santa Margarita, CA 92688. Customers with product return questions, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at [email protected]. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at [email protected].
Quantity in commerce: 20,247 units total
Distribution: Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.
Product codes and lots: 1112662,1115821,1121413,1122062, 1122163,1125949,1129996,1130225, 1131354

Product code DXC

K883790Class IISurgical Clamp InsertsApplied Vascular Devices, Inc. / cleared 1988-12-27

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)