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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a manufacturing defect affecting a critical component of a surgical instrument, but no injuries or hospitalizations have been reported. The hazard is theoretical based on the manufacturing process defect.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Crocodile Grasper (model SP90-7066), a 5mm endoscopic surgical device with a 32cm shaft and ratcheted handle. This is a Class II medical device recall.
The affected units may have a cracked or broken rotation knob due to incorrect use of adhesive during the manufacturing process. This defect could potentially compromise the device's functionality during endoscopic surgical procedures.
The recalled lot is B23, with UDI/DI 10885403160769. Distribution was in the United States and Canada. No injuries or illnesses have been reported.
Healthcare facilities and medical professionals who have received this product should stop using the affected lot and contact Carefusion 2200 Inc for return or replacement instructions.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- device-failure
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10885403160769
- Lot Number B23
Distribution
Distribution scope not specified by the agency.
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