FDA (Devices) recall action 92561
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
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 recalls Snowden-Pencer MIS Diamond-Touch Clamps (Lot B23) due to potential cracking of the rotation knob from incorrect adhesive use. The 7 affected units were distributed to the US and Canada.
Carefusion 2200 Inc is recalling specific lots of Snowden-Pencer MIS DIAMOND-TOUCH surgical clamps because the rotation knob may crack or break due to a manufacturing defect. Lots B23 and C23 are affected.
Carefusion is recalling specific lots of Snowden-Pencer surgical graspers used in endoscopy due to a manufacturing defect that could cause the rotation knob to crack or break. The affected instrument may malfunction during surgical procedures.
Carefusion is recalling specific lots of Snowden-Pencer Diamond-Touch endoscopic graspers due to a manufacturing defect that may cause the rotation knob to crack or break. Affected units were distributed in the US and Canada.
Carefusion 2200 Inc is recalling Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR endoscopic surgical instruments due to potential cracking of the rotation knob from incorrect adhesive use in manufacturing. Lot B23 is affected.
Carefusion is recalling Snowden-Pencer MIS surgical graspers (lot B23) distributed in the US and Canada because the rotation knob may crack or break due to a manufacturing adhesive defect. Affected devices could malfunction during surgical use.
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS surgical dissector because the rotation knob may crack or break due to a manufacturing defect.
Carefusion is recalling specific lots of surgical graspers due to potential cracking of the rotation knob caused by incorrect adhesive use in manufacturing. Affected devices may fail during surgical procedures.
Carefusion 2200 Inc recalls 42 units of Snowden-Pencer surgical dissectors distributed in the US and Canada due to potential cracking of the rotation knob caused by an adhesive defect in manufacturing.
Carefusion is recalling Snowden-Pencer endoscopic graspers due to potential rotation knob cracking from a manufacturing adhesive defect. Affected lot B23 was distributed in the US and Canada.
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer DIAMOND-TOUCH GRASPER endoscopic surgical instrument due to a manufacturing defect that may cause the rotation knob to crack or break, potentially compromising surgical performance.
Snowden-Pencer endoscopic surgical clamps may have rotation knobs that crack or break due to manufacturing defect. Lot B23 units should not be used.
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.
Carefusion is recalling specific lots of Snowden-Pencer MIS endoscopic surgical clamps due to potential cracking or breaking of the rotation knob caused by incorrect adhesive use during manufacturing.
Specific lots of Snowden-Pencer surgical clamps may have rotation knobs that crack or break due to incorrect adhesive use in manufacturing. Eight units with lot numbers L22, B23, or C23 distributed in the US and Canada are affected.