The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2420-2023·Announced 2023-08-23

Endoscopic surgical clamp recalled for defective rotation knob

Carefusion 2200 Inc is recalling specific lots of Snowden-Pencer MIS DIAMOND-TOUCH surgical clamps because the rotation knob may crack or break due to a manufacturing defect. Lots B23 and C23 are affected.

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: FDA Class II medical device with a manufacturing defect posing a risk of harm (potential rotation knob failure during surgical use), but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High.

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY surgical clamp (Reference SP90-7044), an endoscopic surgical device. The recalled lot numbers are B23 and C23, with distribution in the United States and Canada.

The recall was announced because the rotation knob on these clamps has the potential to crack or break due to incorrect adhesive use during manufacturing. This manufacturing defect could affect device function during surgical procedures.

Facilities, practitioners, and institutions using these specific lots should identify any affected devices and contact Carefusion 2200 Inc regarding replacement or additional guidance.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Clamps
Hazard

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 (3)

  • UDI/DI 10885403160554
  • Lot Numbers: B23
  • C23

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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