Z-0966-2019Class II

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

Name: Z-0966-2019 Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-12-20
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-12-20 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 on 2018-12-20. FDA classified it as Class II and gives the reason as "Presence of natural rubber latex is not declared in the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0966-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Posted: 2019-02-27
Terminated: 2019-08-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Presence of natural rubber latex is not declared in the label
Root cause tag: design
FDA root cause: Component design/selection
Action: Terumo issued Urgent Medical Device Recall dated 12/20/18 stating reason for recall, health risk and an appropriate course of action for the return of affected product to Terumo. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET.
Quantity in commerce: 12 packs
Distribution: TX
Product codes and lots: Lot Numbers: V A30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0966-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0966-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)