FDAClass IJune 26, 2013

GlideScope Video Laryngoscope recall

GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are…

Why was GlideScope Video Laryngoscope recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
Verathon, Inc.
Quantity
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.
Recall date
June 26, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls