Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2400-2020Class II

Mueller Knife Handle, Hexagonal -

Medtronic, Inc. / initiated 2020-05-18 / Terminated / root cause: supplier

Carefusion 2200 Inc began a recall of Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades on . FDA classified it as Class II and gives the reason 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...". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-2400-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Product code
EMF Knife, Surgical
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.
Root cause tag
supplier
FDA root cause
Under Investigation by firm
Action
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 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 affected product (both collet and handle assembly) following your institutions process for discarding. If discarding is not immediately possible at your facility, then product should be quarantined until disposal. 2. This recall should be carried out to the user level. If you have further distributed any of the affected product, please contact that location immediately and advise them of the recall, forward these instructions and have them complete the instructions within this recall notification. 3. Share this recall notification with all users of the product within your institution to ensure they are also aware of this recall. 4. Complete the attached Customer Response Form and return it to the contact noted on the form regardless of whether you have any affected product or not so that BD may acknowledge your receipt of this notification. Indicate on the response form the quantity of affected product identified at your facility and confirm that this inventory has been discarded. Credit will be issued to customers for all discarded product. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.
Quantity in commerce
358 units
Distribution
US Nationwide distribution including in the states of CA, FL, VA and KY.
Product codes and lots
Model Numbers: OP0702 and OP0703. Model OP0702, Lot C20VAA ( 4 inch length) Model OP0703, Lot D17VAA (6 inch length)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2400-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2400-2020Class IITerminatedVoluntary: Firm initiated