The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2417-2023·Announced 2023-08-23

Endoscopic surgical graspers recalled for potential rotation knob cracking

Carefusion is recalling Snowden-Pencer MIS surgical graspers (lot B23) distributed in the US and Canada because the rotation knob may crack or break due to a manufacturing adhesive defect. Affected devices could malfunction during surgical use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II recall of a surgical instrument with a manufacturing defect that could cause the rotation knob to malfunction during use. No illnesses or injuries have been reported, and the hazard remains theoretical. The classification as a risk-of-harm product without reported injury justifies a High severity score.

Plain-English summary

Carefusion 2200 Inc is recalling the Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED (reference number SP90-7020), an endoscopic surgical instrument used during minimally invasive procedures. The recall affects devices with lot number B23 (UDI/DI 10885403159725).

The recalled devices have the potential to exhibit cracking or breaking of the rotation knob due to incorrect use of adhesive during the manufacturing process. This manufacturing defect could cause the knob to malfunction or fail during surgical use.

The affected devices were distributed in the US and Canada. Healthcare facilities and surgical centers that have received devices from this lot should identify and quarantine them.

Healthcare providers who have these devices should immediately discontinue use and contact Carefusion 2200 Inc for instructions on replacement or return.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1

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 10885403159725
  • Lot Number B23

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 15 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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