FDAOctober 13, 2023device

AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

avanos medicalavanos

UPCs

00609038945064

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation — Recall Details · AllClear