FDA Device recall Z-0832-2013
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into…
- FDA Device
- Class II
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class II recall of CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into… by Carefusion 303, citing careFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0832-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-20 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
Reason
CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
Identifiers
| code_info | Lot number 12055225 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0832-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.