FDAFDA · Food and drugs·Recall number Z-1995-2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
Published July 18, 2012 · Recall initiated: June 1, 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
Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PSC Industries Inc
- Distributor
- Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
- Lot
- Model/part Number: 41604, Lot Number: 019737, and 021578.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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