Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
This recall has been terminated (originally issued January 7, 2013).
- Recall Initiated
- November 5, 2012
- Posted
- January 7, 2013
- Terminated
- January 16, 2013
- Recall Number
- Z-0644-2013
- Quantity
- 72 units
- Firm Location
- Margarita, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - USA (nationwide) and France.
Lot / Code Info
Lot Number: 1179107
Root Cause
Nonconforming Material/Component
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.