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U.S. Department of Health and Human Services

Class 1 Device Recall The GlideScope Video Laryngoscope GVL 3, 4, 5 and AVL 2, 3, 4 and 5

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 Class 1 Recall
The GlideScope Video Laryngoscope GVL 3, 4, 5 and AVL 2, 3, 4 and 5
see related information
Date Posted June 20, 2013
Recall Status1 Terminated on December 17, 2013
Recall Number Z-1558-2013
Recall Event ID 65129
Product Classification Laryngoscope, Rigid - Product Code CCW
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Verathon, Inc.
20001 N Creek Pkwy
Bothell, Washington 98011-8218
For Additional Information Contact Verathon Customer Care
800-331-2313
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
Action Verathon issued an Urgent - Safety Alert and Medical Device Recall letter, dated May 10, 2013, to all affected customers The letter identified the affected product, problem and actions to be taken. The letter advises customers to discontinue the use of the specific serial numbers listed in the letter and asked that the affected product be returned to Verathon for replacement. The customers are also directed to fill out a return response form (included in the letter) regarding this recall. Consignees with questions are directed to contact their Verathon representative or Verathon Customer Care at 800-331-2313 (US and Canada) and 1-425-867-1348 for those consignees outside of US and Canada. the support team will be available Monday through Friday from 6 AM - 5 PM PST for the US and from 6 AM to 4:30 pm PST outside the US. Alternately they can e-mail Verathon at customerservice@verathon.com.
Quantity in Commerce 4784 units worldwide (3,381 in the US and 1403 international)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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