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.
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: This is a surgical device with a structural defect (FDA Class II) that poses a risk of harm, but no injuries, illnesses, or deaths have been reported. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW surgical instrument. The product is a 5-millimeter, 45-centimeter endoscopic surgical dissector with ratcheted design (Reference SP90-7271). Affected lot numbers are B23 and C23, with approximately 20 units distributed to customers in the US and Canada.
The rotation knob on affected units may crack or break due to incorrect use of an adhesive during the manufacturing process. This structural defect could impair device function during surgical procedures.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 20
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 10885403161544
- 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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