The Recall Desk
HighFDA (Devices)·Z-2425-2023·Announced 2023-08-23

Endoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking

Carefusion 2200 Inc recalls 42 units of Snowden-Pencer surgical dissectors distributed in the US and Canada due to potential cracking of the rotation knob caused by an adhesive defect in 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: Class II medical device recall involving a structural defect in a surgical instrument with no reported injuries or adverse events. The hazard is potential rather than confirmed, consistent with high-risk 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 DISSECTOR, a 5mm endoscopic surgical dissector. The recall affects 42 units distributed in the US and Canada with lot numbers L22, B23, and C23.

The recalled devices have the potential to develop cracking or breaking of the rotation knob due to incorrect use of adhesive in the manufacturing process. This defect could prevent proper operation of the instrument during surgery.

Device identification: Reference SP90-7071, UDI/DI 10885403160790. This is a Class II recall from the FDA.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
  • device-malfunction
  • 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 (4)

  • UDI/DI 10885403160790
  • Lot Numbers: L22
  • B23
  • C23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category