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.
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 FDA Class II medical device recall where a critical component can crack or break due to manufacturing defect. Although no injuries or hospitalizations have been reported, this surgical instrument's potential failure during use presents a risk of harm. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of Snowden-Pencer MIS Diamond-Touch clamps used in endoscopic surgery. The recall involves eight units with UDI/DI 10885403160547 and lot numbers L22, B23, and C23.
The rotation knobs on affected units have the potential to crack or break due to incorrect adhesive use during the manufacturing process. This defect could affect the instrument's functionality during surgical use.
Affected lot numbers L22, B23, and C23 were distributed to the US and Canada. Healthcare facilities and practitioners using this product should verify their lot numbers against the recall notice.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- mechanical-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 (4)
- UDI/DI 10885403160547
- Lot Numbers: L22
- B23
- C23
Distribution
Distribution scope not specified by the agency.
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