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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT EC8 Cartridge

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  Class 2 Device Recall iSTAT EC8 Cartridge see related information
Date Initiated by Firm October 18, 2007
Date Posted December 11, 2007
Recall Status1 Terminated 3 on July 18, 2008
Recall Number Z-0374-2008
Recall Event ID 44972
510(K)Number K894914  K912387  K001154  K936081  
Product Classification Ion Specific Electrode (Sodium) - Product Code JGS
Product Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
Code Information Catalog Number: 06F04-01; 06F04-02 Lot Numbers: A07110 and A07153.
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
104 Windsor Center Dr
East Windsor NJ 08520
For Additional Information Contact
609-443-9300
Manufacturer Reason
for Recall		 Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
FDA Determined
Cause 2		 Packaging change control
Action Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
Distribution Worldwide Distribution- including USA and country of Canada.
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 = JGS and Original Applicant = I-STAT CORP.
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