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 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 is recalling 259 surgical bipolar forceps units because the Instructions for Use are missing critical information about power supply interface and maintenance procedures.
BD is recalling Carefusion V. Mueller Bipolar Forceps due to incomplete Instructions for Use lacking critical content about power supply interface and cleaning procedures.
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 V. Mueller bipolar forceps (Ref F-5073) recalled due to missing critical instructions for power supply interface and cleaning and maintenance procedures. Users should obtain the complete Instructions For Use from the manufacturer.
CareFusion bipolar forceps are being recalled due to missing Instructions for Use content about power supply interface, cleaning, and maintenance. Users should obtain the complete manufacturer instructions immediately.
Carefusion is recalling 218 units of surgical bipolar forceps due to incomplete product instructions. The Instructions For Use is missing information about 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 is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.
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.
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 surgical bipolar forceps due to incomplete instructions for use. The missing information covers power supply interface and cleaning and maintenance procedures.
CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.
Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to 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 bipolar surgical forceps are being recalled because their instruction manual is missing critical information about power supply interface and cleaning procedures. BD is providing corrected instructions to healthcare facilities.
CareFusion bipolar forceps (REF F-5061) recalled due to incomplete Instructions for Use missing device power supply interface and cleaning instruction content.
CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.
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.
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.