Class II — CAREFUSION
| Recalling firm | CAREFUSION |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. |
| Product | MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. |
| Quantity | 100 units |
| Distribution | U.S.: TN O.U.S.: None |
| Initiated | 2021-06-09 |
| Classified | 2021-07-01 |
| Terminated | 2024-07-08 |
| Recall number | Z-1995-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CAREFUSION (Z-1995-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88104/
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