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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Latex Free NeoGuard Transducer Cover

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  Class 2 Device Recall CIVCO Latex Free NeoGuard Transducer Cover see related information
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
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
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
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) Database 510(K)s with Product Code = ITX and Original Applicant = CIVCO MEDICAL INSTRUMENTS CO., INC.
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