NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For sing

FDA device recall Z-1165-2015 · posted 2015-02-26 · Terminated

Recall details

Recalling firm

Navilyst Medical, Inc

Reason for recall

The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

Action taken

Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.

Root cause

Packaging

Status

Terminated

Product code

OEZ

Quantity affected

105 units

Distribution

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

Date initiated

2015-01-09

Date posted

2015-02-26

Date terminated

2017-03-10

Location

Glens Falls, NY