Endoscopic Surgical Clamp Recalled Due to Potential Rotation Knob Failure
Carefusion is recalling specific lots of Snowden-Pencer MIS endoscopic surgical clamps due to potential cracking or breaking of the rotation knob caused by incorrect adhesive use during manufacturing.
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 risk-of-harm medical device where a structural component (rotation knob) could fail during use, but no injuries or illnesses have been reported. The defect is tied to a manufacturing error and affects critical surgical functionality.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL endoscopic surgical device. The affected product is a 60 mm jaw, 5 mm, 32 cm ratcheted surgical clamp used in endoscopic procedures.
The recalled units (lot numbers C23 and L22) have the potential to develop cracks or breaks in the rotation knob due to incorrect adhesive used during the manufacturing process. If the knob cracks or breaks during a procedure, it could compromise the device's functionality and safety.
The recalled devices were distributed in the United States and Canada. Healthcare providers and facilities using devices from the affected lots should discontinue use immediately and contact Carefusion 2200 Inc or their healthcare supplier for guidance on replacement, return, or proper disposal of the recalled units.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 4
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 10885403160578
- Lot Numbers: C23
- L22
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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