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Recall Observatory FDA recall evidence

Device product

Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

Z-1994-2012

June 01, 2012

Class II

Product summary

Firm
PSC Industries Inc
Event
Event 61958
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-1994-2012

Official wording

Reason: Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.

Code information: Model/part Number: 90-7004, Lot Numbers: 017897

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