ClearanceBrief
Recall Z-2400-2020 ยท EMF Knife, Surgical

Carefusion 2200 Inc

Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.

DateMay 18, 2020
StatusTerminated
ReasonBecton 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.
Root causeUnder Investigation by firm
ActionBecton 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 contain a machining burr, potentially causing the collet to not fully seat in the knife handle, inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade. BD is asking consignees to: Please check all inventory locations within your institution for the affected Catalog No/Lot number combination listed in the recall notice. Discard all affe
Quantity358 units
DistributionUS Nationwide distribution including in the states of CA, FL, VA and KY.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.