FDA Medical Device Recalls (openFDA)
Sirtex Medical Limited: SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
- Recall number
- Z-1275-2021
- Recalling firm
- Sirtex Medical Limited
- Product
- SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
- Status
- Terminated
- Initiated
- 2021-02-22
- Posted
- 2021-03-18
- Terminated
- 2023-04-17
- Reason
- There is a potential presence of particulate matter in the D-Vial.
- 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 QA@sirtex.com. 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 CSUSA@sirtex.com 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
- 3310
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Numbers: 1031234, 1031225, 1031227, 1031229
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWJ
- Firm FEI
- 3003428886
- Firm city
- not on file
- Firm state
- New South Wales
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28