FDAFDA · Food and drugs·Recall number Z-2212-2016
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Published August 3, 2016 · Recall initiated: July 1, 2016
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
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion 2200 Inc
- Distributor
- Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
- Lot
- Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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