Food, drugs, devices › Carefusion 2200 Inc
Device recall: Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Carefusion 2200 Inc (Vernon Hills, IL) initiated this device recall on 18 May 2020; FDA lists 1 product record under event 85747, 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 25 Apr 2021. Initiation: voluntary: firm initiated. Carefusion 2200 Inc has 16 enforcement events on this register, with a median of 2 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 2200 Inc, Vernon Hills, IL.
Reason for recall
"Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade…"
Distribution
"US Nationwide distribution including in the states of CA, FL, VA and KY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2400-2020 | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades. | 358 units | Class II | Terminated | 24 Jun 2020 |
Context
Other enforcement events for Carefusion 2200 Inc
All 16 events for Carefusion 2200 Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade…"
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: "US Nationwide distribution including in the states of CA, FL, VA and KY."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Apr 2021. "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.