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FDA device recall Z-0644-2013 · posted 2013-01-07 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.

Action taken

Applied Medical sent an Urgent Medical Device Recall to all affected customers in November 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indcated any product their facility is returning. The Recall confirmation form should be returned to Applied Medical by emailing to recall60494844#applied medical.com or fax to 949-713-8832. Return affecte4d product and a copy of the confirmation form to Applied Medical. Customers with questions were instructed to call 949-713-8662. For questions regarding this recall 949-713-8662.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CGJ

Quantity affected

72 units

Distribution

Worldwide Distribution - USA (nationwide) and France.

Date initiated

2012-11-05

Date posted

2013-01-07

Date terminated

2013-01-16

Location

Rancho Santa Margarita, CA

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