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 Fresenius

  • 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 Fresenius see related information
Date Initiated by Firm January 21, 2003
Date Posted June 05, 2003
Recall Status1 Terminated 3 on June 04, 2003
Recall Number Z-0906-03
Recall Event ID 25528
510(K)Number K960006  K984233  K012178  
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir.

The component that is the subject of the recall is the AT1 Autotransfusion Set.
Code Information ATF 40 Fast Start Kit -  Catalog no. 9108491, batch no. NKT257  AT1: Catalog no. 9005101, lot no. NHT272
Recalling Firm/
Manufacturer		 Fresenius Hemocare, Inc.
6675 185th Ave. NE
Suite 100
Redmond WA 98052
Manufacturer Reason
for Recall		 Sterility may be compromised
FDA Determined
Cause 2		 Other
Action On 1/21/03 the firm notified, via telephone, the distributor of the product. The distributor was advised to return any unused product and to contact their customers for return of product. This was followed by a letter 1/21/03 sent via e-mail. The distributor in turn contacted their customers on 1/23/03 by telephone. This was followed by a letter dated 1/23/03.
Quantity in Commerce ATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)
Distribution All ATF 40 kits were distributed to one distributor located in MI. The distributor in turn distributed product to 21 hospitals and medical centers in AL, FL, NE, KS, MI, NE, NJ, NY, OH, PA, TX, VA, and WA.
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 = CAC and Original Applicant = FRESENIUS AG
510(K)s with Product Code = CAC and Original Applicant = FRESENIUS HEMOTECHNOLOGY, INC.
-
-