SmartSite Low Sorbing Infusion Set — Class II medical device recall Z-1053-2015
Terminated recall by CareFusion 303, Inc., reported 2015-02-11, distributed nationwide. CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
| Recall number | Z-1053-2015 |
|---|---|
| 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 | 2015-01-13 |
| Classified | 2015-02-04 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 7,440 units |
| Reason classes | packaging |
| Lot numbers | 12056016, 12057027, 12107105 |
| Model numbers | 10015862 |
Product
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.
Reason for recall
CareFusion is recalling the SmartSite Low Sorbing Infusion 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-1053-2015. 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.