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 3 Device Recall iSTAT EG7 Cartridge

  • 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 3 Device Recall iSTAT EG7 Cartridge see related information
Date Initiated by Firm February 23, 2009
Date Posted June 18, 2009
Recall Status1 Terminated 3 on July 29, 2009
Recall Number Z-1540-2009
Recall Event ID 51211
510(K)Number K940918  K934642  K894914  K912387  
Product Classification Blood-Gases (PCO2, PO2) and Blood pH Electrode Measurement - Product Code CHL
Product i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct.
Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300.
Abbott Point of Care inc., Abbott Park, IL 60064 USA

Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
Code Information Lot number P08274A, Box numbers: 0822, 0823, 0824, 0831, 0832, 0833, 0834, 0841, 0842, 0843, 0844, 0851, 0852, 0853, 0854, 0861, 0862, 0863, 0864, 0871, 0872, 0873, and 0874. 
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
104 Windsor Center Dr
East Windsor NJ 08520
For Additional Information Contact Peter Scott
609-454-9270
Manufacturer Reason
for Recall		 Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
FDA Determined
Cause 2		 Packaging process control
Action Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.
Quantity in Commerce 1048 boxes of 25 cartridges each.
Distribution Worldwide Distribution -- USA, Austria, China, India, Saudi Arabia, South Africa, and Taiwan.
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.
-
-