FDA Device recall Z-1995-2021
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injecti…
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injecti… by Carefusion, citing A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1995-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-09 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion |
| Distribution | TN |
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
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Identifiers
| code_info | Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.