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U.S. Department of Health and Human Services

Class 2 Device Recall Radiometer Copenhagen ABL77 Cal Pack

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 Class 2 Device Recall Radiometer Copenhagen ABL77 Cal Packsee related information
Date Initiated by FirmJune 19, 2007
Date PostedAugust 18, 2007
Recall Status1 Terminated 3 on November 07, 2011
Recall NumberZ-1173-2007
Recall Event ID 38359
510(K)NumberK994346 
Product Classification electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
Code Information Lot Number 17323
Recalling Firm/
Manufacturer		 Sendx Medical Inc
1945 Palomar Oaks Way
Carlsbad CA 92009-1307
For Additional Information ContactDoreen E. Milford
760-603-3401
Manufacturer Reason
for Recall		Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.
FDA Determined
Cause 2		Other
ActionA total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261. All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system.
Quantity in Commerce69
DistributionWorldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CHL
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