Endoscopic Dissector Surgical Tool Recalled for Cracking Knob Defect
Carefusion 2200 Inc is recalling Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR endoscopic surgical instruments due to potential cracking of the rotation knob from incorrect adhesive use in manufacturing. Lot B23 is affected.
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 FDA Class II recall involves a manufacturing defect in a surgical instrument with potential to impair function during use. No illnesses or injuries have been reported, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc has recalled the Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED, model reference SP90-7036, an endoscopic surgical instrument. The affected lot is B23 (UDI/DI 10885403159862).
The rotation knob on specific units may crack or break due to incorrect adhesive use during the manufacturing process. A defect in the knob could affect the operation of the instrument during surgical use.
No illnesses or injuries have been reported. The product was distributed in the United States and Canada.
Facilities with affected units should contact Carefusion 2200 Inc for further instructions regarding their inventory.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
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 10885403159862
- Lot Number B23
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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