| Class 3 Device Recall S1730 Calibration Solution 2, 200 mL, REF 944025. | |
Date Initiated by Firm | October 31, 2005 |
Date Posted | August 29, 2006 |
Recall Status1 |
Terminated 3 on April 17, 2012 |
Recall Number | Z-1460-06 |
Recall Event ID |
35663 |
Product Classification |
Calibration solution - Product Code CHL
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Product | S1730 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
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For Additional Information Contact | Vince 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 |
Action | Representatives 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 Commerce | 638/200 mL plastic bottles. |
Distribution | The 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 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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