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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Healthcare Corp.

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  Class 2 Device Recall Baxter Healthcare Corp. see related information
Date Initiated by Firm August 18, 2015
Create Date June 07, 2016
Recall Status1 Terminated 3 on May 31, 2018
Recall Number Z-1922-2016
Recall Event ID 74125
510(K)Number K082575  K081979  K071206  K090850  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product Actifuse ABX/Actifuse MIS System

A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Code Information Product Code: 506005078050 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078051 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078052 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078058 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078060 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078070 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078072 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017 
Recalling Firm/
Manufacturer
Apatech Limited
370 Centennial Ave
Elstree United Kingdom
Manufacturer Reason
for Recall
Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
FDA Determined
Cause 2
Process control
Action The firm, Baxter, sent an "Urgent Product Recall Notification" letter dated 8/18/2015 and a follow-up letter date 4/29/2016 to consignees via FedEx, overnight mail. Baxter also notified affected customers by phone. The letters described the product, problem and actions to be take. Baxter Healthcare has instructed customers to do the following: 1. Locate and remove all affected product from their facilities. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. Complete the attached customer reply form and return it to Baxter by either fax it to 224-270-5457 or scanned e-mail to fca@baxter.com. 4. If you distribute this product to other facilities or departments with your institution, notify all affected parties of this communication. For general questions regarding this communication, please call Baxter's Therapeutic Medical Affairs at 805-657-0007 or 862-432-7941.
Quantity in Commerce 11696 units
Distribution Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.
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 = MQV and Original Applicant = APATECH LTD.
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