Date Initiated by Firm | January 21, 2011 |
Date Posted | March 08, 2011 |
Recall Status1 |
Terminated 3 on July 09, 2013 |
Recall Number | Z-1607-2011 |
Recall Event ID |
57759 |
510(K)Number | K013721 |
Product Classification |
Diagnostic Ultrasonic Transducer - Product Code ITX
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Product | CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA. |
Code Information |
Lots M615880, M598520, M591150, and M581180. |
Recalling Firm/ Manufacturer |
Civco Medical Instruments Inc 102 1st St S Kalona IA 52247-9589
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For Additional Information Contact | James Leong 319-248-6502 |
Manufacturer Reason for Recall | Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information. |
FDA Determined Cause 2 | Labeling design |
Action | The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST. |
Quantity in Commerce | 31/24-cover boxes |
Distribution | Nationwide Distribution -- WA, CA, and MO. |
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 = ITX
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