Drug recall
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on…
FDA recall event 93305 · Class II · Avanos Medical, Inc.
Key facts
| Event ID | 93305 |
|---|---|
| Recall numbers | Z-0360-2024 |
| Recalling firm | Avanos Medical, Inc. |
| Product type | Devices |
| Products | AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 13, 2023 |
| Report date | Nov 29, 2023 |
| City | Alpharetta |
| State | GA |
| Country | United States |
| FEI number | 3011270181 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: