Z-0478-2013 Class I Terminated
FDA device recall Z-0478-2013 was initiated by Verathon, Inc. on October 25, 2012 and is designated Class I. Reason for recall: Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking. The recall status is terminated (terminated September 27, 2013). Affected quantity: total 2710 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2012
- Initiation Date
- October 25, 2012
- Termination Date
- September 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- total 2710 units
Product Description
Reason for Recall
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.