FDA Device recall Z-0221-2016
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient'…
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient'… by Carefusion 303, citing careFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0221-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-09 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Reason
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Identifiers
| code_info | Lot No. 15015769, 15035412, 15045950. |
|---|
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-0221-2016%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.