Enforcement Report - Week of November 7, 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. Product Usage: 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-0159-2013 |
| Classification | Class II |
| Code Info | Lot 1104-01 |
| Product Distributed Qty | 124 boxes |
| Reason For Recall | The tip of the product could come loose or unravel. |
Event Detail
| Event Id | 62386 |
|---|---|
| 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 | 2011-10-28 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI. |
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