The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2100-2014·Announced 2014-07-30

Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate

Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

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: The recall involves a high-risk medical device used in surgery where particulate contamination poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns Two-stage Venous Return Cannulae, Part No. 4442, 14992, 4443, and 15949. The 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. A total of 6,720 units are affected by this recall.

The affected units were distributed worldwide, including nationwide in the United States and in Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, the United Arab Emirates, and the United Kingdom. Healthcare facilities and distributors should stop using the affected lots and contact Terumo CVS for instructions on return or replacement.

The recalled product

Product
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Cannula
Hazard
Affected units
6,720

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)

  • Part No. 4442
  • Lot #:
  • 0646528
  • 0649147
  • 0649840
  • 0654076
  • 0662223
  • 0678729
  • Part No. 14992
  • Lot #: 0646475
  • 0649160
  • 0655317
  • 0659466
  • 0666649
  • 0672081
  • 0675675
  • 0681806
  • 0686885
  • Part No. 4443
  • Lot #: 0649883

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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