Recall Z-1852-2017— Verathon Inc
Class II · Terminated
Class II FDA medical device recall by Verathon Inc, initiated 2017-03-03, terminated 2017-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.. Reason: Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades))..
- Recalling firm
- Verathon Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-03
- Terminated
- 2017-08-28
- Firm location
- Bothell, WA, United States
Product description
It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.
Reason for recall
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Data sourced from openFDA. This site is unofficial and independent of the FDA.