Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3 0574-0007, GVL 4 0574-0001, and GVL 5 0574-0030. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. |
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| Recall Number | Z-0478-2013 |
| Classification | Class I |
| Code Info | Serial numbers range for GVL3: 0574-0007/ MD10500 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798. |
| Product Distributed Qty | total 2710 units |
| Reason For Recall | Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking. |
Event Detail
| Event Id | 63635 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Verathon, Inc. |
| City | Bothell |
| State | WA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-25 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela. |
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