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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter HomeChoice Automated PD Set with Lineo Connector

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 Class 2 Device Recall Baxter HomeChoice Automated PD Set with Lineo Connectorsee related information
Date Initiated by FirmDecember 05, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 30, 2004
Recall NumberZ-0340-04
Recall Event ID 27896
510(K)NumberK031676 
Product Classification Accessories, Catheter - Product Code KGZ
ProductBaxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case
Code Information Product code R5C4479Q, lots H03J01492, H03J17027 and H03J24056 and product code N5C4479Q, lots H03I10114, H03I12078, H03J05030 and H03J15088
FEI Number 1416980
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Reports of loosening of the connections and disconnection of the device.
FDA Determined
Cause 2		Other
ActionBaxter sent recall letters dated 12/5/03 to the accounts in the United Kingdom and recall letters dated 12/8/03 to the accounts in Canada, informing them of the reports of loosening of the connections and disconnection of the device, and requesting that they discontinue use of product codes involved and revert the enrolled patients back to their traditional connection system.
Quantity in Commerce10,030 units
DistributionCanada and the United Kingdom
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 = KGZ
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