U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Filler, bone void, calcium compound - Product Code MQV
원인
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.
조치
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.
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
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.
제품 설명
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.