Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue. |
|---|---|
| Recall Number | Z-1999-2012 |
| Classification | Class II |
| Code Info | Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017. |
| Product Distributed Qty | 125 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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