Recall Z-0644-2013 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Applied Medical Resources Corp
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.
| Date | Jan 7, 2013 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 confir |
| Quantity | 72 units |
| Distribution | Worldwide Distribution - USA (nationwide) and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072674 | KII TROCAR SYSTEM Applied Medical Resources Corp., Oct 5, 2007 |