CareFusion SmartSite Gravity Blood Set Model 42082E — Class II medical device recall Z-0832-2013
Terminated recall by Carefusion 303 Inc, reported 2013-02-27, distributed nationwide. CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the conn
| Recall number | Z-0832-2013 |
|---|---|
| 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 | 2012-12-20 |
| Classified | 2013-02-15 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2013-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 5,050 units |
| Lot numbers | 12055225 |
| Model numbers | 42082E |
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 for recall
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.
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-0832-2013. 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.