FDAFDA · Food and drugs·Recall number Z-1558-2013
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: 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. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
Published June 26, 2013 · Recall initiated: May 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Verathon, Inc.
- Distributor
- Worldwide distribution: USA (nationwide) including states of : AK, AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Washington DC, Guam, and countries of : Argentina, Australia, Brazil, Canada, China, Ecuador, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Japan, Malaysia, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, The Netherlands, United Kingdom, and Venezuela.
- Lot
- Model, Part and Serial Numbers: Model # GVL 3, Part # 0574-0007, Serial # range MD112388 to MD121908; Model # GVL 4 Part # 0574-0001 Serial # range LG112759 to LG122582; Model # GVL 5 Part # 0574-0030 Serial # range XL111799 to XL121759; Model # AVL 2 Part # 0574-0118 Serial # range AC111500 to AC121604; Model # AVL 3 Part # 0574-0115 Serial # range AD111500 to AD121688; Model # AVL 4 Part # 0574-0116 Serial # range AE11150 to AE121778; and Model # AVL 5 Part # 0574-0117 Serial # range AF111500 to AF121666.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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