VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Wi

FDA device recall Z-1208-2010 · posted 2010-03-25 · Terminated

Recall details

Recalling firm

Marina Medical Instruments Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HDQ

Quantity affected

22

Distribution

Nationwide distribution.

Date initiated

2009-04-09

Date posted

2010-03-25

Date terminated

2010-09-03

Location

Sunrise, FL