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Class 3 Device Recall iSTAT EG7 Cartridge |
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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
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Product Classification |
Blood-Gases (PCO2, PO2) and Blood pH Electrode Measurement - Product Code CHL
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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
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For Additional Information Contact |
Peter Scott 609-454-9270
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Manufacturer Reason for Recall |
Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
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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
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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.
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510(K) Database |
510(K)s with Product Code = CHL and Original Applicant = I-STAT CORP.
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