The Recall Desk
HighFDA (Devices)·Z-0159-2015·Announced 2014-11-12

Terumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect

Terumo is recalling specific cardiovascular and perfusion procedure kits because a luer connector defect may compromise the seal and introduce air into the table line.

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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (air introduction into a medical line) where no specific injuries or illnesses are reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corp is recalling specific Custom Cardiovascular and Perfusion Procedure Kits. The affected products include kits with 5-digit catalog codes beginning with 6 (Catalog Number 6XXXX) and kits with 5-digit catalog codes beginning with 7 (Catalog Number 7XXXX). The recall covers 4,561 units of the 6XXXX kits and 19,356 units of the 7XXXX kits.

The recall is due to a defect in the luer connector that can compromise the seal on the female side of the connector. This compromised seal can introduce air into the table line. The products are indicated for use in cardiopulmonary bypass surgery and for the delivery of cardioplegic solutions to the heart.

The affected lots were manufactured between September 7, 2010, and December 13, 2010. Specific lot numbers for the 6XXXX kits include ML07, MM18, MM25, MN08, MN IS, and MN22. Specific lot numbers for the 7XXXX kits include ML07, ML20, MM18, MM25, MNO1, MN08, MN15, MN29, MP06, and MP13. The products were distributed worldwide, including the United States, Canada, Brazil, Hong Kong, Korea, and Thailand. Users should stop using the affected kits and contact the manufacturer for instructions.

The recalled product

Product
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardiopleg
Manufacturer
Terumo Cardiovascular Systems Corp
Category
Medical Device — Cardiovascular Procedure Kits
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 (16)

  • Catalog Number: 6XXXX Lot Numbers: ML07
  • MM18
  • MM25
  • MN08
  • MN IS
  • MN22. Manufacturing dates September 7
  • 20 I 0 through November 22
  • 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07
  • ML20
  • MNO1
  • MN15
  • MN29
  • MP06
  • MP13. Manufacturing dates September 7
  • 2010 through December 13
  • 2010.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Terumo Cardiovascular Systems Corp 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 6 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corp

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Same hazard · air introduction

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