NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Mad

FDA device recall Z-0821-2012 · posted 2012-01-19 · Terminated

Recall details

Recalling firm

Navilyst Medical, Inc

Reason for recall

Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures.

Action taken

Navilyst Medical sent an Urgent Medical Device Recall- Immediate Action Required letter dated December 19, 2011 and a Reply Verification Tracking Form to all affected consignees via Federal Express or email. The letter identified the product, description of problem, and actions to be taken Customers were instructed to 1) IMMEDIATELY DISCONTINUE USE; 2) remove the recalled product from your inventory (whether in Labs, Central Supply, Shipping and Receiving or ANY other location); 3) segregate this product in a secure location for return to Navilyst Medical, Inc; 4) immediately forward a copy of this recall notification to all sites to which you have distributed affected product; 5) complete and return the Reply Verification Tracking Form; and 6) package and return the recalled product per the instruction provided.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OEZ

Quantity affected

4547

Distribution

Worldwide Distribution - USA (nationwide) including the states of Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Ohio, South Carolina, Wisconsin, Virginia

Date initiated

2011-12-19

Date posted

2012-01-19

Date terminated

2015-04-07

Location

Glens Falls, NY