Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Hemofiltration Standard Pack including BC 60 PlusT 8036

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Hemofiltration Standard Pack including BC 60 PlusT 8036 see related information
Date Initiated by Firm May 22, 2017
Date Posted December 20, 2017
Recall Status1 Terminated 3 on July 12, 2018
Recall Number Z-0490-2018
Recall Event ID 78765
510(K)Number K053025  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Product Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990.

Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
Code Information Lot/batch number: 3000001571 UDI code: 607567206489
Recalling Firm/
Manufacturer		 Maquet
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact Allison Jean Kaplan
973-709-7779
Manufacturer Reason
for Recall		 55 kits were distributed after their expiration date of September 2015.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Medical Device Recall (Removal) Notices were sent to customers via FedEx on 5/22/2017. The letters identified the affected device and the issue. Users are asked to examine their inventory to determine if any of the affected product is on hand. If found, affected devices should be removed and quarantined. Customers should contact Maquet/Getinge Customer Support at 1-888-627-8383 to obtain instructions on returning the affected devices. The Medical Device Recall Removal Response Form provided should be completed and returned. Questions should be directed to your Maquet/Getinge representative or call the Maquet/Getinge Customer Support at 1-888-627-8383.
Quantity in Commerce 55 units
Distribution Distributed to the states of NM, CA, and IL.
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 = DWE and Original Applicant = MAQUET CARDIOPULMONARY AG
-
-