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U.S. Department of Health and Human Services

Class 3 Device Recall S1730 Calibration Solution 2, 200 mL, REF 944025.

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 Class 3 Device Recall S1730 Calibration Solution 2, 200 mL, REF 944025.see related information
Date Initiated by FirmOctober 31, 2005
Date PostedAugust 29, 2006
Recall Status1 Terminated 3 on April 17, 2012
Recall NumberZ-1460-06
Recall Event ID 35663
Product Classification Calibration solution - Product Code CHL
ProductS1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
Code Information Part #944-025, Lot QR-02, Expiration Date: September 2007.
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information ContactVince Sigmund
800-736-0600
Manufacturer Reason
for Recall
Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.
FDA Determined
Cause 2
Other
ActionRepresentatives of the recalling firm were informed of this problem and were asked to visit the firm''s customers and retrieve any of the suspect product found in inventory at each customer location for customer credit. The representatives were instructed to complete this action via a ''Management Cover e-mail issued on 10/31/2005. According to the Management Cover Memo, these actions were scheduled for completion by firm representatives on or before 12/15/2005.
Quantity in Commerce638/200 mL plastic bottles.
DistributionThe recalled product was distributed to customers in following states nationwide: AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV and WY
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.
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