The Recall Desk
HighFDA (Devices)·Z-2422-2023·Announced 2023-08-23

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.

What this means for you

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
Hazard
  • mechanical-failure
  • manufacturing-defect

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.