FDA Recall
Open, Classified
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Recall: Z-0360-2024
·
Initiated October 13, 2023
Recall
- Recall Number
- Z-0360-2024
- Event Number
- 93305
- Firm
- Avanos Medical, Inc.
- FEI Number
- 3011270181
- Product Code
- BSY
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- October 13, 2023
- Posted
- November 21, 2023
- Address
- 5405 Windward Pkwy, Alpharetta, GA, 30004-3894
Description
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.
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.
Distribution
US and South Africa
Quantity
4730 cases (94600 devices)