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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