Date Initiated by Firm | February 06, 2020 |
Create Date | April 30, 2020 |
Recall Status1 |
Terminated 3 on June 01, 2021 |
Recall Number | Z-1832-2020 |
Recall Event ID |
85007 |
510(K)Number | K072093 K110823 |
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product | Prismaflex System, Prismaflex Control Unit |
Code Information |
Product Code:955542; GTIN 07332414124236 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
|
For Additional Information Contact | Center for One Baxter 847-948-4770 |
Manufacturer Reason for Recall | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Baxter is asking customers to:
1. Operators may continue to safely use the Prismaflex control unit according to the
warnings and cautions in the Prismaflex Operators Manual.
2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email. |
Quantity in Commerce | 626 |
Distribution | Distribution in US, Puerto Rico |
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.
|
510(K) Database | 510(K)s with Product Code = KDI 510(K)s with Product Code = KDI
|