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Recall Observatory FDA recall evidence

Device product

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

Z-2400-2020

May 18, 2020

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 85747
Status
Terminated
Classification
Class II
Quantity
358 units
Official record key
device-enforcement:Z-2400-2020

Official wording

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.

Code information: Model Numbers: OP0702 and OP0703. Model OP0702, Lot C20VAA ( 4 inch length) Model OP0703, Lot D17VAA (6 inch length)

Distribution pattern: US Nationwide distribution including in the states of CA, FL, VA and KY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.