FDA recall Z-2400-2020

Carefusion 2200 Inc · Class II · device

Product

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-05-18
Report date
2020-06-24
Termination date
2021-04-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2400-2020