Z-1275-2021Class II

SIROS D-Vial Prep Set, Product Code SIR-10200 -

Name: Z-1275-2021 SIROS D-Vial Prep Set, Product Code SIR-10200 -
Creator: Sirtex Medical Limited
Published: 2021-02-22
License: https://open.fda.gov/license/

Sirtex Medical Inc. / initiated 2021-02-22 / Terminated

FDA source

Sirtex Medical Limited began a recall of SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use on 2021-02-22. FDA classified it as Class II and gives the reason as "There is a potential presence of particulate matter in the D-Vial". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1275-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-22
Posted: 2021-03-18
Terminated: 2023-04-17
Recalling firm: Sirtex Medical Inc.
Product: SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Product code: IWJ System, Applicator, Radionuclide, Manual
Reason for recall: There is a potential presence of particulate matter in the D-Vial.
FDA root cause: Other
Action: Urgent Voluntary Medical Device Recall notification letters dated 2/22/21 were distributed to customers. Actions to be taken by the Customer/User: Sirtex is directing customers not to use the product from the recalled lots. Recalled product should be returned to Sirtex for credit. Please forward the notice in the event affected products were further distributed. Please fill out and return the attached Customer Acknowledgement and Receipt Form to [email protected]. Please complete this form whether or not you have affected product on hand. A mailing label will be provided via email for the return of the product once the form is received. Credit will be issued upon return of the product. Contact Sirtex Medical Customer Service at +1-888-474-7839, Monday through Friday, between the hours of 8 a.m. and 5 p.m., EST or via email [email protected] for assistance in returning affected product. Unaffected lots of Sirtex Legacy V-Vial product is available for replacement. Customers with questions regarding this recall can call Sirtex at +1-888-474-7839, Monday through Friday, between the hours of 8 a.m. and 5 p.m. EST and ask to speak with the Quality Assurance Department. Type of Action by the Company: Sirtex is working with our contract manufacturer to address the particulate issue. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 3310
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: 1031234, 1031225, 1031227, 1031229

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1275-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1275-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-18

Product code IWJ

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)