SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

FDA device recall Z-1275-2021 · posted 2021-03-18 · Terminated

Recall details

Recalling firm

Sirtex Medical Limited

Reason for recall

There is a potential presence of particulate matter in the D-Vial.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IWJ

Quantity affected

3310

Distribution

US Nationwide distribution.

Date initiated

2021-02-22

Date posted

2021-03-18

Date terminated

2023-04-17

Location

New South Wales, Australia