FDA Device recall Z-0350-2024
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 40…
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 40… by Becton Dickinson And, citing affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0350-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-11 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
Reason
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Identifiers
| code_info | UDI-DI: 10885403240867, Catalog # 4030B-07T; UDI-DI: 07613203020855, Catalog # 42081E. All lots, thru expiration date July 31, 2026. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0350-2024%22
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