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U.S. Department of Health and Human Services

Class 2 Device Recall VNVD Veronikis Neo Vaginal Dilator Tip/Set

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  Class 2 Device Recall VNVD Veronikis Neo Vaginal Dilator Tip/Set see related information
Date Initiated by Firm April 09, 2009
Date Posted March 25, 2010
Recall Status1 Terminated 3 on September 03, 2010
Recall Number Z-1208-2010
Recall Event ID 53501
Product Classification Dilator, Cervical, Fixed Size - Product Code HDQ
Product VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100,
VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually),
VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually).

For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.
Code Information Product No.: 270-100, 270-115, 270-125, 270-135, 270-145, 270-155, 270-165, 270-175, 270-185, 270-195, 270-199.
Recalling Firm/
Manufacturer		 Marina Medical Instruments Inc.
955 Shotgun Rd
Sunrise FL 33326-1964
For Additional Information Contact Lisa Barron
954-924-4418
Manufacturer Reason
for Recall		 Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A "PRODUCT RECALL NOTICE" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.
Quantity in Commerce 22
Distribution Nationwide distribution.
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.
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