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Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me

Recalled November 29, 2023 · FDA recall Z-0360-2024 · Avanos Medical

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. · FDA Class II
Units
4730 cases (94600 devices)
Sold at
US and South Africa

Description

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.

Product
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Manufacturer(s)
Avanos Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me | RecallWatchUSA