Z-0202-2022Class II

Aspiration Syringe Kit, REF: MVSK60

Name: Z-0202-2022 Aspiration Syringe Kit, REF: MVSK60
Creator: Microvention Inc.
Published: 2021-10-20
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2021-10-20 / Terminated / root cause: labeling and UDI

FDA source

MICROVENTION INC. began a recall of Aspiration Syringe Kit, REF: MVSK60 on 2021-10-20. FDA classified it as Class II and gives the reason as "Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers". 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-0202-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-20
Posted: 2021-11-04
Terminated: 2024-05-15
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Aspiration Syringe Kit, REF: MVSK60
Product code: FMF Syringe, Piston
Reason for recall: Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 10/20/21, recall notices were sent to customers. Customers were asked to identify and quarantine all impacted kits. Complete and return the response form. Return affected devices to the manufacturer including a copy of the completed response form. The following contact information was provided to customers with additional questions: [email protected], and 714-247-8143 or 949-501-0355, Hours: Monday -Friday PST 8:00-5:00 pm.
Quantity in commerce: 33
Distribution: US Nationwide distribution in the states of AL, NY, NV.
Product codes and lots: Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0202-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0202-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-04

Product code FMF

K994253Class IIVaclok SyringeMerit Medical Systems, Inc. / cleared 2000-01-05

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)