Z-2550-2018Class II

Tubing Pack Convenience Kit, Product Code 65217

Name: Z-2550-2018 Tubing Pack Convenience Kit, Product Code 65217
Creator: Terumo Cardiovascular Systems Corp
Published: 2017-05-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2017-05-12 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corp began a recall of Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for... on 2017-05-12. FDA classified it as Class II and gives the reason as "Kit was labeled with the incorrect Expiration Date of April 30, 2019". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2550-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-12
Posted: 2018-07-26
Terminated: 2018-10-26
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
Quantity in commerce: 30 cases/2 units (Total 60 units)
Distribution: US state of FL
Product codes and lots: Lot Number: VE17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2550-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2550-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-26

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)