The Recall Desk
HighFDA (Devices)·Z-2423-2023·Announced 2023-08-23

Surgical grasper recalled for rotation knob cracking due to adhesive defect

Carefusion is recalling Snowden-Pencer endoscopic graspers due to potential rotation knob cracking from a manufacturing adhesive defect. Affected lot B23 was distributed in 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: This is a Class II recall involving a surgical instrument with a manufacturing defect that creates a risk of device failure during use. While no injuries have been reported, a grasper malfunction during endoscopic surgery could pose patient safety risks.

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE (Reference SP90-7048), a curved 5mm endoscopic surgical grasper. The affected instruments have the potential to develop cracks or break in the rotation knob due to incorrect use of adhesive during manufacturing.

Lot Number B23 (UDI/DI 10885403160592) is subject to this recall. The devices were distributed to medical facilities in the United States and Canada.

Malfunction of the rotation knob could occur during surgical use. Healthcare providers with affected units should contact Carefusion 2200 Inc regarding this recall.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument / Endoscopic
Hazard
  • rotation-knob-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 10885403160592
  • Lot Number B23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category