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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Bicarbonate Jug Adapter

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  Class 2 Device Recall Fresenius Bicarbonate Jug Adapter see related information
Date Initiated by Firm December 17, 2013
Date Posted February 03, 2014
Recall Status1 Terminated 3 on May 18, 2021
Recall Number Z-0920-2014
Recall Event ID 66953
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine
Part Number: 650103.

The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
Code Information N/A
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall		 Bicarbonate Jug Adapter distributed prior to 510(k) approval
FDA Determined
Cause 2		 No Marketing Application
Action Fresenius notified customers by telephone and Formal notification on 12/17/13 via the Urgent Bicarbonate Jug Adapter Recall letter sent certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they are instructed to discontinue use and place all Bicarbonate Jug Adapters in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product.
Quantity in Commerce 703 units
Distribution 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.
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