Device product
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.
Z-1995-2012
Product summary
- Event
- Event 61958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1995-2012
Official wording
Reason: 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).
Code information: Model/part Number: 41604, Lot Number: 019737, and 021578.
Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
Derived failure modes
-
Labeling or packaging
misbranded