Recall Z-0916-2020
King Systems Corp. dba Ambu, Inc. · initiated November 5, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12
Codes / lots: Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666
Reason for recall
Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.
FDA-determined cause: Nonconforming Material/Component
Action taken
King Systems issued notification letter -Urgent Medical Device Recall to Domestic consignees notified via E-mail on 11/5/19 with attached letters and forms. Foreign consignees were notified according to local regulation. On January 24, 2020, King Systems issued a Press Release dated 1/20/2020. Customers are advised to take the following action: 1) Review your current inventory and place any affected products in quarantine immediately. 2) The affected products should NOT be used. 3) Please note any affected quantity of product(s) on the attached form and return it within 30 days from the date of this letter by email to Shelby Mitchell (shmi@ambu.com). King Systems asks that you please return all affected product(s). Please contact Shelby Mitchell at +l (410) 768-6464 or email shmi@ambu.com to arrange Return Authorization and credit/replacement
Details
- Recall number
- Z-0916-2020
- Initiated
- November 5, 2019
- Posted by FDA
- February 4, 2020
- Terminated
- March 23, 2021
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 171 units
- Distribution
- Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.
- Recalling firm
- King Systems Corp. dba Ambu, Inc., Noblesville, IN