Surgical grasper recalled for rotation knob cracking due to adhesive defect
Carefusion is recalling Snowden-Pencer endoscopic graspers due to potential rotation knob cracking from a manufacturing adhesive defect. Affected lot B23 was distributed in the US and Canada.
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 Class II recall involving a surgical instrument with a manufacturing defect that creates a risk of device failure during use. While no injuries have been reported, a grasper malfunction during endoscopic surgery could pose patient safety risks.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE (Reference SP90-7048), a curved 5mm endoscopic surgical grasper. The affected instruments have the potential to develop cracks or break in the rotation knob due to incorrect use of adhesive during manufacturing.
Lot Number B23 (UDI/DI 10885403160592) is subject to this recall. The devices were distributed to medical facilities in the United States and Canada.
Malfunction of the rotation knob could occur during surgical use. Healthcare providers with affected units should contact Carefusion 2200 Inc regarding this recall.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; 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 10885403160592
- 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
Same manufacturer · Carefusion 2200 Inc
See all →- HighEndoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
- HighSurgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
Same hazard · rotation knob failure
See all →- HighEndoscopic Dissector Surgical Tool Recalled for Cracking Knob Defect
FDA (Devices) · 2023-08-23
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