Z-0949-2022Class II

Cardiovascular Procedure Kit catalog # 76645 & 73806

Name: Z-0949-2022 Cardiovascular Procedure Kit catalog # 76645 & 73806
Creator: Terumo Cardiovascular Systems Corp
Published: 2022-02-03
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2022-02-03 / Terminated / root cause: packaging

FDA source

Terumo Cardiovascular Systems Corp began a recall of Cardiovascular Procedure Kit catalog # 76645 & 73806 on 2022-02-03. FDA classified it as Class II and gives the reason as "Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0949-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-03
Posted: 2022-04-18
Terminated: 2024-02-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Cardiovascular Procedure Kit catalog # 76645 & 73806
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.
Quantity in commerce: 64
Distribution: US Nationwide distribution in the states of CA and IN.
Product codes and lots: [Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0949-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0949-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)