Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 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. |
|---|---|
| Recall Number | Z-1996-2012 |
| Classification | Class II |
| Code Info | Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017. |
| Product Distributed Qty | 80 units |
| Reason For Recall | Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date. |
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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