Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 Product Usage: Applied Medical's C

FDA device recall Z-3068-2011 · posted 2011-08-24 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in a tip breakage.

Action taken

Applied Medical Resources Corp. notified customers via an overnight "URGENT: MEDICAL DEVICE RECALL" letter dated December 22, 2009. The letter informed customers of the recalled products, problem, and actions to be taken. The letter asked that the listed recalled products be returned immediately. The customers were asked to check their inventory, complete the attached Voluntary Recall Notification Confirmation Form and fax as per the instructions. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).

Root cause

Component design/selection

Status

Terminated

Product code

GCJ

Quantity affected

13,791 units total

Distribution

Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ir

Date initiated

2009-12-18

Date posted

2011-08-24

Date terminated

2011-09-06

Location

Rancho Santa Margarita, CA

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