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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO SurgiTip Transducer cover

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  Class 2 Device Recall CIVCO SurgiTip Transducer cover see related information
Date Initiated by Firm July 20, 2010
Date Posted August 20, 2010
Recall Status1 Terminated 3 on April 13, 2012
Recall Number Z-2242-2010
Recall Event ID 56285
510(K)Number K013721  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
Code Information Lot M538160
Recalling Firm/
Manufacturer		 Civco Medical Instruments Inc
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact James Leong
319-656-4447
Manufacturer Reason
for Recall		 Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.
Quantity in Commerce 22 boxes
Distribution Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
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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