CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report
Tubing Pack Convenience Kit, Product recalled
Terumo Cardiovascular Systems is recalling Tubing Pack Convenience Kit, distributed in Florida. The recall was initiated on 12 May 2017 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-2550-2018
- FDA event ID
- 80283
- Recalling firm
- Terumo Cardiovascular Systems, Ashland, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2017
- FDA classified
- 26 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 May 2017 | Recall initiated by company | |
| 26 Jul 2018 | Classified by FDA | +440 days |
| 1 Aug 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Product as listed by the FDA
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Where it was distributed
US state of FL
Questions about this recall
Why was it recalled?
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Which lots are affected?
Lot Number: VE17
Where was it sold?
US state of FL
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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