Recall Z-2672-2014 ยท FMI Needle, Hypodermic, Single Lumen
Vidacare Corporation
EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
| Date | Sep 22, 2014 (initiated Mar 31, 2014) |
| Status | Terminated |
| Reason | The voluntary recall is due to the needle set not meeting its specifications. |
| Root cause | Material/Component Contamination |
| Action | Vidacare sent an Urgent Medical Device Recall Notification to all of its customers on March 31, 2014.The letter identified the product the problem and the action to be taken by the customers. The firm asked its customers to return the affected lot for a replacement. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any product with the part number and lot number as identified above 2 To return product. complete the enclosed Medical Device Recall Acknowledgment and Return Response Form and fax it to 1 866-431-6194, Attn "Customer Service" T |
| Quantity | 172 |
| Distribution | Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052408 | EZ-IO Vidacare Corporation, Nov 17, 2005 |