Recalls / —

—#181673

Product

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

FDA product code

EMF — Knife, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-05-18

Terminated

2021-04-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.