| Class 2 Device Recall TheraSphere | |
Date Initiated by Firm | July 23, 2021 |
Date Posted | August 19, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2327-2021 |
Recall Event ID |
88369 |
PMA Number | P200029 |
Product Classification |
Microspheres radionuclide - Product Code NAW
|
Product | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) |
Code Information |
GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
|
For Additional Information Contact | Rebecca KinKead Rubio 763-494-1133 |
Manufacturer Reason for Recall | Potential for leaks and loosening at the patient catheter connection |
FDA Determined Cause 2 | Component change control |
Action | The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery. The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration. |
Quantity in Commerce | 4980 sets |
Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database | PMAs with Product Code = NAW
|
|
|
|