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.
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: Class II medical device recall involving a structural defect in a surgical instrument with no reported injuries or adverse events. The hazard is potential rather than confirmed, consistent with high-risk 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 DISSECTOR, a 5mm endoscopic surgical dissector. The recall affects 42 units distributed in the US and Canada with lot numbers L22, B23, and C23.
The recalled devices have the potential to develop cracking or breaking of the rotation knob due to incorrect use of adhesive in the manufacturing process. This defect could prevent proper operation of the instrument during surgery.
Device identification: Reference SP90-7071, UDI/DI 10885403160790. This is a Class II recall from the FDA.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 42
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 10885403160790
- Lot Numbers: L22
- 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.
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