Recall Z-2400-2020— Carefusion 2200 Inc
Class II · Terminated
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2020-05-18, terminated 2021-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.. Reason: 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 possibly resulting in a loose blade..
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-18
- Terminated
- 2021-04-25
- Firm location
- Vernon Hills, IL, United States
Product description
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
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 possibly resulting in a loose blade.
Data sourced from openFDA. This site is unofficial and independent of the FDA.