SmartSite Add-On Bag Access Device — Class II medical device recall Z-1883-2017
Terminated recall by CareFusion 303, Inc., reported 2017-05-03. CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between t
| Recall number | Z-1883-2017 |
|---|---|
| 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 | 2016-11-17 |
| Classified | 2017-04-27 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2018-10-29 |
| Quantity | 384,923 units |
| Reason classes | packaging |
| Model numbers | 10013365 |
Product
SmartSite Add-On Bag Access Device, Model No. 10013365
Reason for recall
CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
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-1883-2017. 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.