FDA (Devices) recall action 92561

Carefusion 2200 Inc recalled 15 products on 2023-08-23

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.

Products: 15
Announced: 2023-08-23
Critical: 0
Units: 92

Why these products were recalled

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.

1–15 of 15

HighFDA (Devices)··2023-08-23
Endoscopic surgical graspers recalled for potential rotation knob cracking
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic surgical graspers recalled for potential rotation knob failure
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Surgical clamp rotation knob may crack or break due to manufacturing defect
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Surgical Clamp Recall: Rotation Knob May Crack or Break
Snowden-Pencer endoscopic surgical clamps may have rotation knobs that crack or break due to manufacturing defect. Lot B23 units should not be used.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic surgical clamp recalled for defective rotation knob
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic Surgical Grasper Recalled for Potential Rotation Knob Cracking
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic Dissector Surgical Tool Recalled for Cracking Knob Defect
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic Surgical Clamp Recalled Due to Potential Rotation Knob Failure
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Surgical grasper recalled for rotation knob cracking due to adhesive defect
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic surgical clamp recalled for potential rotation knob failure
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic Grasper Instrument Recalled for Rotation Knob Failure Risk
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Endoscopic surgical grasper recalled due to rotation knob defect
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
Category
Distribution
0 states
HighFDA (Devices)··2023-08-23
Snowden-Pencer Surgical Dissector Rotation Knob May Crack or Break
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.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Category
Distribution
0 states