The Recall Desk
HighFDA (Devices)·Z-2421-2023·Announced 2023-08-23

Surgical Clamp Recall: Rotation Knob May Crack or Break

Snowden-Pencer endoscopic surgical clamps may have rotation knobs that crack or break due to manufacturing defect. Lot B23 units should not be used.

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 with no reported injuries or adverse events. However, the potential cracking or breaking of the rotation knob on an endoscopic surgical device presents a risk of harm to surgical procedures. This constitutes a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL (Reference SP90-7045) is an endoscopic surgical device manufactured by Carefusion 2200 Inc.

Specific units from Lot Number B23 have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive during the manufacturing process.

This recall affects 2 units that were distributed in the United States and Canada. The UDI/DI is 10885403160561.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instruments
Hazard
  • mechanical-failure
  • rotation-knob-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 10885403160561
  • Lot Number B23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category