Surgical Clamp Recall: Rotation Knob May Crack or Break
Snowden-Pencer endoscopic surgical clamps may have rotation knobs that crack or break due to manufacturing defect. Lot B23 units should not be used.
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: FDA Class II recall with no reported injuries or adverse events. However, the potential cracking or breaking of the rotation knob on an endoscopic surgical device presents a risk of harm to surgical procedures. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL (Reference SP90-7045) is an endoscopic surgical device manufactured by Carefusion 2200 Inc.
Specific units from Lot Number B23 have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive during the manufacturing process.
This recall affects 2 units that were distributed in the United States and Canada. The UDI/DI is 10885403160561.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 2
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 10885403160561
- 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 Grasper Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical clamp recalled for defective rotation knob
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- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
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- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
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