Recall Z-0821-2012 ยท OEZ Cardiovascular Procedure Kit
Navilyst Medical, Inc
NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. Product usage: For use in fluid management and/or invasive pressure monitoring sys
| Date | Jan 19, 2012 (initiated Dec 19, 2011) |
| Status | Terminated |
| Reason | Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures. |
| Root cause | Nonconforming Material/Component |
| Action | 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 o |
| Quantity | 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 and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.