Recall Z-1207-2010 ยท HDQ Dilator, Cervical, Fixed Size
Marina Medical Instruments Inc.
VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes: VVD Veronikis Vaginal Dilator - 3cm Tip: Width: 1.00in Catalog No. 270-003 (sold individually) VVD Veronikis Vaginal Dilator - 5cm Tip: Width: 1.00in Cat No. 270-005 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Tip: Width: 1.00in Catalog Np. 270-007 (sold individually) VVD Veronikis Vaginal Dilator - 1cm
| Date | Mar 25, 2010 (initiated Apr 9, 2009) |
| Status | Terminated |
| Reason | Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 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. |
| Root cause | 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 | 27 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.