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U.S. Department of Health and Human Services

Class 2 Device Recall ISTAT EG7 Cartridge

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  Class 2 Device Recall ISTAT EG7 Cartridge see related information
Date Initiated by Firm January 01, 2011
Date Posted August 02, 2012
Recall Status1 Terminated 3 on May 22, 2013
Recall Number Z-2133-2012
Recall Event ID 62371
510(K)Number K940918  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ.

The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Code Information List number 03P76-25 Lot number S10246A
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Mr. Joseph Kiceina
609-454-9494
Manufacturer Reason
for Recall		 i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Abbott Point of Care, Inc sent a Urgent Recall Notice letter dated January 14, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of Cartridges from the identified lot. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. If you have any questions regarding this information please contact your Abbott Point of Care Technical Support at 800-366-8020 Option 1, or your Abbott Point of Care representative.
Quantity in Commerce 52,750 cartridges
Distribution USA ( nationwide )
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 = CHL and Original Applicant = I-STAT CORP.
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