Device Recall Surgical Clamp Inserts 의 리콜

Recall

59416

Class 2

Z-3006-2011

2011-03-07

2011-08-11

Terminated

United States

2012-03-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102722

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.

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.