Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analy

FDA device recall Z-1133-2010 · posted 2010-03-15 · Terminated

Recall details

Recalling firm

Abbott Point of Care Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

CGA

Quantity affected

6432 printers (1208 have already been returned and repaired or scrapped)

Distribution

Worldwide distribution

Date initiated

2009-11-06

Date posted

2010-03-15

Date terminated

2011-09-14

Location

Princeton, NJ

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