VersaSafe Extension Set — Class II medical device recall Z-0435-2014
Terminated recall by CareFusion 303, Inc., reported 2013-12-11, distributed nationwide. CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive
| Recall number | Z-0435-2014 |
|---|---|
| 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 | 2013-11-08 |
| Classified | 2013-12-03 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,500 units |
| Lot numbers | 13066550 |
| Model numbers | 21000M-007 |
Product
VersaSafe Extension Set, Model No. 21000M-007
Reason for recall
CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
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-0435-2014. 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.