The Recall Desk
HighFDA (Devices)·Z-2415-2023·Announced 2023-08-23

Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.

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 medical device with potential for functional failure during surgical use. No injuries or illnesses have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.

Plain-English summary

Carefusion 2200 Inc is recalling Snowden-Pencer MIS Diamond-Touch Grasper McKernan Fundus endoscopic surgical instruments (5mm, 32cm, Reference SP90-7012) due to a manufacturing defect in the rotation knob.

Specific lots of this surgical grasper have the potential to develop cracking or breaking of the rotation knob due to incorrect use of adhesive during the manufacturing process. This defect could affect the functionality of the instrument during surgical use.

This recall affects 3 units with Lot Number B23 and UDI/DI 10885403159671, distributed in the United States and Canada. Healthcare providers who have received affected units should contact Carefusion 2200 Inc for appropriate action.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
  • cracking
  • device-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 (2)

  • UDI/DI 10885403159671
  • Lot Number B23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category