Recall Z-0644-2013— Applied Medical Resources Corp
Class II · Terminated
Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2012-11-05, terminated 2013-01-16. It names one FDA 510(k) clearance: K072674. Product: 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.. 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..
- Recalling firm
- Applied Medical Resources Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-05
- Terminated
- 2013-01-16
- Firm location
- Rancho Santa Margarita, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.