Enforcement Report - Week of November 21, 2012
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Product Detail
| Product Description | Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. |
|---|---|
| Recall Number | Z-0276-2013 |
| Classification | Class II |
| Code Info | Lot 1108-01 |
| Product Distributed Qty | 70 boxes |
| Reason For Recall | Some of the sterile packages had broken seals. |
Event Detail
| Event Id | 63445 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Progressive Medical Inc |
| City | Saint Louis |
| State | MO | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-12-09 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI. |
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