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

FDA Device Recall #Z-2400-2020 — Class II — May 18, 2020

Recall Summary

Recall Number Z-2400-2020
Classification Class II — Moderate risk
Date Initiated May 18, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Carefusion 2200 Inc
Location Vernon Hills, IL
Product Type Devices
Quantity 358 units

Product Description

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 Pattern

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

Lot / Code Information

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

Other Recalls from Carefusion 2200 Inc

Recall # Classification Product Date
Z-2429-2023 Class II Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAM... Jul 13, 2023
Z-2421-2023 Class II Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 5... Jul 13, 2023
Z-2418-2023 Class II Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENE... Jul 13, 2023
Z-2417-2023 Class II Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GR... Jul 13, 2023
Z-2420-2023 Class II Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY... Jul 13, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.