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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II device with potential for failure during use due to manufacturing defect, but no injuries or illnesses have been reported. Classified as 'High' under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER (Reference SP90-7266), an endoscopic surgical instrument used in minimally invasive surgery.
The recalled devices have the potential to crack or break at the rotation knob due to incorrect adhesive use during manufacturing. Failure of this component during surgical use could impact device function.
The recall affects devices distributed in the United States and Canada with UDI/DI 10885403161513, specifically lot numbers B23 and C23.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 1
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 (3)
- UDI/DI 10885403161513
- Lot Numbers: B23
- C23
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
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