Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SIROS DVial Prep Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SIROS DVial Prep Set see related information
Date Initiated by Firm February 22, 2021
Date Posted March 18, 2021
Recall Status1 Terminated 3 on April 17, 2023
Recall Number Z-1275-2021
Recall Event ID 87393
Product Classification System, applicator, radionuclide, manual - Product Code IWJ
Product SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Code Information Lot Numbers: 1031234, 1031225, 1031227, 1031229
Recalling Firm/
Manufacturer		 Sirtex Medical Limited
Centrecourt Business Park,
Unit D4, 25-27, Paul Street North
North Ryde, New South Wales Australia
Manufacturer Reason
for Recall		 There is a potential presence of particulate matter in the D-Vial.
FDA Determined
Cause 2		 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 in Commerce 3310
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-