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U.S. Department of Health and Human Services

Class 2 Device Recall Martel Printer

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  Class 2 Device Recall Martel Printer see related information
Date Initiated by Firm November 06, 2009
Date Posted March 15, 2010
Recall Status1 Terminated 3 on September 14, 2011
Recall Number Z-1133-2010
Recall Event ID 53674
510(K)Number K001387  
Product Classification Printer - Product Code CGA
Product Martel Printer

The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.
Code Information List number 06F23-91/111300; Abbott list number: 06F23-91 Serial numbers between 20091081 and 241248976.
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter Scott
609-454-9270
Manufacturer Reason
for Recall		 Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
FDA Determined
Cause 2		 Component design/selection
Action An "Urgent Recall Notice" dated October 2009 was sent to customers. The notice described the product, problem and action to be taken by the customers. The customers are requested to remove the printers from use, if they have a Martel printer with the specified serial numbers, that do not have a battery door for access to the rechargeable battery pack. The customers are ask to turn in to Abbott Point of Care or a designated repair facility, all affected Martel printers for battery pack replacement. Abbott will return the Martel printers to your facility at no charge. The customers are ask to please follow the instructions on the enclosed customer reply cared. If in doubt regarding identification of the affected Martel printers, contact Abbott Point of Care Technical Support. If you have any questions regarding this information or if removing the affected Martel printers from use will negatively impact patient care, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.
Quantity in Commerce 6432 printers (1208 have already been returned and repaired or scrapped)
Distribution Worldwide distribution
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 = CGA and Original Applicant = I-STAT CORP.
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