| Class 2 Device Recall | |
Date Initiated by Firm | July 27, 2004 |
Date Posted | August 10, 2004 |
Recall Status1 |
Terminated 3 on October 29, 2004 |
Recall Number | Z-1331-04 |
Recall Event ID |
29652 |
510(K)Number | K971221 |
Product Classification |
Tubes, Vacuum Sample, With Anticoagulant - Product Code GIM
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Product | Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile. |
Code Information |
Item no. 454332, Lot number B040404 |
Recalling Firm/ Manufacturer |
Greiner VACUETTE North America 4238 Capital Dr Monroe NC 28110-7681
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For Additional Information Contact | Manfred Pillichshammer 704-261-7823 |
Manufacturer Reason for Recall | Coagulation tubes may not have received the proper fill of citrate solution. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by letter on 7/28/2004. |
Quantity in Commerce | 314 cases (376,800 pieces) |
Distribution | Nationwide |
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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510(K) Database | 510(K)s with Product Code = GIM
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