The Recall Desk
ModerateFDA (Devices)·Z-2104-2014·Announced 2014-07-30

Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate

Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality control deviation (loose fiber particulate) identified during inspection, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 2,290 units of Three-stage Venous Return Cannulae. The affected products include 28 Fr with 3/8" flare (Part No. 816460), 30 Fr with 3/8" connector (Part No. 820732), and 30 Fr with 3/8" flare (Part No. 820731). These devices are indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected lots are distributed nationwide in the United States and in several international countries, including Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, the United Arab Emirates, and the United Kingdom.

Healthcare providers and facilities should stop using the affected lots immediately. Terumo Cardiovascular Systems Corporation is the recalling firm responsible for managing the recall.

The recalled product

Product
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Cannulae
Hazard
Affected units
2,290

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 (20)

  • 28 Fr with 3/8" flare
  • Part No.
  • 816460
  • Lot #:
  • 0645280
  • 0649157
  • 0654734
  • 0666686
  • 0674810
  • 0678724
  • 0682221
  • 0684790
  • 0698319
  • 0698910
  • 30 Fr with 3/8" connector
  • 820732
  • 646450 & 30 Fr with 3/8" flare
  • 820731
  • 0689843
  • 0698323

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 13 recalled by Terumo Cardiovascular Systems Corporation 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 13 products in this recall →

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