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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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 Class 2 Device Recall Freseniussee related information
Date Initiated by FirmJanuary 21, 2003
Date PostedJune 05, 2003
Recall Status1 Terminated 3 on June 04, 2003
Recall NumberZ-0906-03
Recall Event ID 25528
510(K)NumberK012178 K960006 K984233 
Product Classification Apparatus, Autotransfusion - Product Code CAC
ProductATF 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
FEI Number 3002987955
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
ActionOn 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 CommerceATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)
DistributionAll 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 CycleTPLC 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) Database510(K)s with Product Code = CAC
510(K)s with Product Code = CAC
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