Enforcement Report - Week of January 16, 2013
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0644-2013 |
| Classification | Class II |
| Code Info | Lot Number: 1179107 |
| Product Distributed Qty | 72 units |
| 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. |
Event Detail
| Event Id | 63842 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Applied Medical Resources Corp |
| City | Rancho Santa Margarita |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-05 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and France. |
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