MaxPlusTM bi fuse extension set with 2 clear needleless connectors — Class II medical device recall Z-1995-2021
Terminated recall by CAREFUSION, reported 2021-07-07, distributed in TN. A portion of a validation lot was inadvertently released to the US Market. The product did not meet the valida
| Recall number | Z-1995-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CAREFUSION, San Diego, CA, United States |
| Recall initiated | 2021-06-09 |
| Classified | 2021-07-01 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2024-07-08 |
| Distributed | TN |
| Quantity | 100 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10885403237157 |
| Lot numbers | 20087194 |
| Model numbers | MP9246-C |
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.
Reason for recall
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
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-1995-2021. 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.