FDAFDA · Food and drugs·Recall number Z-0644-2013
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.
Published January 16, 2013 · Recall initiated: November 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Applied Medical Resources Corp
- Distributor
- Worldwide Distribution - USA (nationwide) and France.
- Lot
- Lot Number: 1179107
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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