FDA (Devices) recall action 90967
The FDA (Devices) publishes a recall like this one as 45 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 45 pages.
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
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The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Carefusion bipolar surgical forceps recalled nationwide due to incomplete Instructions for Use. The distributed IFU is missing guidance on power supply interface and cleaning and maintenance procedures.
CareFusion bipolar forceps recalled due to missing instructions on power supply interface and cleaning/maintenance procedures. Corrected documentation is now available.
Carefusion is recalling bipolar forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning procedures.
CareFusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing power supply interface and maintenance guidance.
CareFusion 2200 Inc is recalling 4,557 units of V. Mueller ADSON Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning and maintenance instructions.
Carefusion is recalling neurosurgical bipolar forceps due to incomplete Instructions for Use. The product is missing critical information about power supply interface and cleaning/maintenance procedures.
Carefusion is recalling bipolar surgical forceps due to incomplete Instructions for Use. The missing instructions cover power supply interface and cleaning procedures.
Carefusion is recalling the V. Mueller Bipolar Forceps Insulated due to missing instructions for power supply interface and cleaning/maintenance procedures.
Carefusion recalled 84 units of HARDY-STYLE BAYONET BIPOLAR FORCEPS nationwide and internationally due to incomplete Instructions for Use. The distributed documentation is missing information about power supply interface, cleaning, and maintenance procedures.
CareFusion V. Mueller bipolar forceps are being recalled because the provided Instructions for Use are missing critical content about power supply interface and cleaning/maintenance. The complete information is available in the manufacturer's full IFU.
BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.
CareFusion bipolar forceps (REF F-5061) recalled due to incomplete Instructions for Use missing device power supply interface and cleaning instruction content.
BD is recalling CareFusion bipolar forceps due to incomplete Instructions for Use. The IFU is missing critical information about power supply interface and cleaning/maintenance procedures.
Carefusion is recalling 418 units of bipolar surgical forceps because the provided instructions lack critical content about power supply interface and maintenance. Complete manufacturer instructions are necessary for safe device operation.
Carefusion V. Mueller bipolar forceps are recalled because their instructions are missing information on power supply interface and cleaning procedures. Users should obtain the complete manufacturer instructions.
Carefusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing critical content on power supply interface and maintenance procedures. Distributed nationwide and internationally.
CareFusion initiated a voluntary recall of bipolar forceps surgical instruments. The recall affects 4 units distributed nationwide and internationally.
Carefusion is recalling bipolar forceps due to missing instructions for use. The corrected instructions address power supply interface, cleaning, and maintenance.
Carefusion 2200 Inc. is recalling 41 units of Hardy Bayonet Irrigating Bipolar Forceps due to incomplete instructions for use. The supplied instructions lack content about device power supply interface and maintenance procedures.
Carefusion recalls bipolar forceps due to incomplete Instructions for Use missing power supply interface and maintenance guidance. No injuries reported.
CareFusion bipolar surgical forceps recalled for incomplete Instructions for Use. Documentation is missing information on power supply interface and cleaning procedures.
Carefusion recalled certain bipolar forceps due to incomplete Instructions For Use. The IFU was missing content about the device's power supply interface and cleaning and maintenance procedures.
BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.
CareFusion bipolar forceps have incomplete Instructions for Use missing power supply interface and maintenance guidance. Users should obtain complete instructions from the manufacturer before use.
CareFusion is recalling 1369 units of V. Mueller bipolar surgical forceps (Model F-1000) due to incomplete instructions for use. The provided instructions lack information about power supply interface and cleaning and maintenance procedures.