Recall Z-0360-2024 ยท BSY Catheters, Suction, Tracheobronchial
Avanos Medical, Inc.
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
| Date | Nov 21, 2023 (initiated Oct 13, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| 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. |
| Quantity | 4730 cases (94600 devices) |
| Distribution | US and South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.