FDA-Device2023-11-29Class II
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Avanos Medical, Inc.
Hazard
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Sold states
US and South Africa
Affected count
4730 cases (94600 devices)
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2024Don't want to check this manually?
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