SmartSite Extension Set — Class II medical device recall Z-0221-2016
Terminated recall by CareFusion 303, Inc., reported 2015-11-11, distributed nationwide. CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
| Recall number | Z-0221-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2015-10-09 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 21,000 units |
| Reason classes | packaging |
| Lot numbers | 15015769, 15035412, 15045950 |
| Model numbers | 20029E |
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 for recall
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0221-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.