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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1995-2012
Classification Class II
Code Info Model/part Number: 41604, Lot Number: 019737, and 021578.
Product Distributed Qty 5 units
Reason For Recall 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).

Event Detail

Event Id 61958
Product Type Devices
Status Ongoing
Recalling Firm PSC Industries Inc
City Louisville
State KY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-01
Initial Firm Notification of Consignee or Public Letter
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.
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