Reported Jan 16, 2013 · Terminated
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive…
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa # 3 · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Number1179107
- Amount recalled
- 72 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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