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Recall Observatory FDA recall evidence

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

June 01, 2012

Class II

Product summary

Firm
PSC Industries Inc
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

    reason.labeling_packaging · v1.0.0

    misbranded