AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me
FDA device recall Z-0360-2024 · posted 2023-11-21 · Open, Classified
Recall details
- Recalling firm
- Avanos Medical, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- BSY
- Quantity affected
- 4730 cases (94600 devices)
- Distribution
- US and South Africa
- Date initiated
- 2023-10-13
- Date posted
- 2023-11-21
- Location
- Alpharetta, GA
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