CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Terumo Custom Cardiovascular System Cardiovascular recalled
Terumo Cardiovascular Systems is recalling Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing, distributed nationwide in the US. The recall was initiated on 25 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2706-2016
- FDA event ID
- 74856
- Recalling firm
- Terumo Cardiovascular Systems, Ashland, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2016
- FDA classified
- 31 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 25 Jul 2016 | Recall initiated by company | |
| 31 Aug 2016 | Classified by FDA | +37 days |
| 7 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. US Product Codes: 72021 72358 71180-01 76021 76022 76023 76024 76025 71801-01 71801-01 71801-01 71801-01 71801-01 74163-03 71296-01 74460-01 74460-01 74460-01 73208-03 74382-01 74382-01 74382-01 74916 74916 74916 70089-07 74063-01 74063-01 74460-01 74460-01 74460-01 74460-01 75252-01 74951 75881 74271-01 71085-02 72742 75314 75368 75368 76095 76095 73339-01 73789 74417 72204 72965-03 73644 73645-01 73700 73861 73871 73901-03 75612 75617 75986 76095 73645-01 73645-01 70099-04 75544 75272 75674 75674 73180 73180 73180 75437 75674 75274 73811 73811 74915 71175-03 73738 76117 75129 75642 75642 72596 72596 72596 75179 74980-01 8340TXC-07 8340TXC-07 8340TXC-07 71875-01 74235-01 74476 75059 75547 75547 74235-01 8351TXC-01 73124 73281-01 73282-01 73874 74477 8340TXC-07 76069 76070 76071 76072 74737 73933 73933 73933 73933 73933 73933 71608-04 75413 74959 75472 75472 75449 75923 75923 73729-01 73730-01 74046-
Where it was distributed
Nationwide Foreign: Canada, Latin America
Questions about this recall
Is Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing recalled?
Yes. Terumo Cardiovascular Systems recalled Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing on 25 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2706-2016.
Why was it recalled?
Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
Which lots are affected?
US Lot Codes: UG06 UE18R UF31 UF31A UF31T UG13 UG13A UG20 UG20T UG27 UG27T OUS Lot Codes: UG13 UG13T UG20 UG20T
Where was it sold?
Nationwide Foreign: Canada, Latin America
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Terumo Cardiovascular Systems
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| Device | CLASS II | CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems | Terumo Cardiovascular Systems | Labeling Errors | Nationwide |
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| Device | CLASS II | Capiox RX15 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
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Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |