Recall Z-0360-2024— Avanos Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Avanos Medical, Inc., initiated 2023-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation. Reason: 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..
- Recalling firm
- Avanos Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-13
- Firm location
- Alpharetta, GA, United States
Product description
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.