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 is recalling 347 units of SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS due to incomplete Instructions for Use. The missing content covers power supply interface and maintenance procedures.
CareFusion is recalling bipolar forceps units due to incomplete instructions for power supply interface and device maintenance. The recall affects devices distributed worldwide.
CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.
CareFusion bipolar forceps recalled nationwide due to incomplete Instructions for Use missing power supply interface and cleaning information. The missing content could affect proper device operation and maintenance.
CareFusion 2200 Inc is recalling V. Mueller bipolar forceps (model F-5304) due to missing Instructions for Use content related to power supply interface and cleaning/maintenance procedures.
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 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 bipolar forceps are recalled due to incomplete manufacturer instructions for use. Missing content covers power supply interface and device maintenance and cleaning procedures.
CareFusion recalls 142 units of bipolar surgical forceps due to incomplete Instructions for Use lacking power supply interface and maintenance guidance found in the manufacturer's version.
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 is recalling the V. Mueller Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, 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.
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.
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 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 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.
CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.
Carefusion is recalling the V. Mueller Jewelers Bipolar Forceps due to incomplete Instructions for Use missing power supply interface and cleaning/maintenance instructions. The recall affects 236 units distributed nationwide and internationally.
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 recalls V. Mueller bipolar forceps with incomplete instructions. The device lacks critical information on power supply interface and cleaning procedures.