Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures. |
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| Recall Number | Z-1998-2012 |
| Classification | Class II |
| Code Info | Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017. |
| Product Distributed Qty | 40 Units |
| Reason For Recall | Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label. |
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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