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Open, Classified

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

FDA Recall Z-0360-2024 · Posted 2023-11-21

Recalling FirmAvanos Medical, Inc.
Recall StatusOpen, Classified
Product CodeBSY
Date Initiated2023-10-13
Product Quantity4730 cases (94600 devices)

Reason for Recall

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.

Firm Action

Avanos medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/13/2023 via FedEx. The notice explained the issue, potential risk to health, and requested that the product be destroyed at the consignee. Distributors were directed to notify their customers.

Root Cause

Labeling Change Control

Distribution Pattern

US and South Africa

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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