Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps and inserts are indicated for sur

FDA device recall Z-3004-2011 · posted 2011-08-11 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

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.

Action taken

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 cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.

Root cause

Other

Status

Terminated

Product code

DXC

Quantity affected

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

Date initiated

2011-03-07

Date posted

2011-08-11

Date terminated

2012-03-26

Location

Rancho Santa Margarita, CA

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