The Recall Desk
HighFDA (Devices)·Z-2427-2023·Announced 2023-08-23

Endoscopic surgical clamp recalled for potential rotation knob failure

Carefusion recalls Snowden-Pencer MIS Diamond-Touch Clamps (Lot B23) due to potential cracking of the rotation knob from incorrect adhesive use. The 7 affected units were distributed to the US and Canada.

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: FDA Class II recall of a surgical instrument with a structural defect (cracking or breaking rotation knob) that poses a risk of harm during use. No injuries or hospitalizations have been reported, so this is scored as High per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Clamp, an endoscopic surgical instrument used in minimally invasive procedures.

The affected product has the potential to experience cracking or breaking of the rotation knob due to incorrect use of an adhesive during the manufacturing process. This defect could affect the instrument's functionality during surgical use.

Only Lot B23 is affected by this recall. A total of 7 units were distributed to the United States and Canada. The product is identified by UDI/DI 10885403161384 and Lot Number B23.

Healthcare facilities and surgeons who have received this product should discontinue use and contact Carefusion 2200 Inc for instructions on how to return or replace the affected clamps.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
  • device-failure
  • structural-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 (2)

  • UDI/DI 10885403161384
  • Lot Number B23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category