Food, drugs, devices › CAREFUSION
Device recall: MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used
CAREFUSION (San Diego, CA) initiated this device recall on 9 Jun 2021; FDA lists 1 product record under event 88104, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 8 Jul 2024. Initiation: voluntary: firm initiated. CAREFUSION has 3 enforcement events on this register, with a median of 9 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CAREFUSION, San Diego, CA.
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."
Distribution
"U.S.: TN O.U.S.: None"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1995-2021 | 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. | 100 units | Class II | Terminated | 7 Jul 2021 |
Context
Other enforcement events for CAREFUSION
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Aug 2022 | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Device | Class II | 9 |
| 2 Aug 2021 | BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E | Device | Class II | 15 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.: TN O.U.S.: None"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Jul 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.