Recall Z-2700-2011 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Vygon Corporation
LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter
| Date | Jun 29, 2011 (initiated Apr 26, 2011) |
| Status | Terminated |
| Reason | Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration. |
| Root cause | Other |
| Action | Vygon Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributo |
| Quantity | 600 individual units |
| Distribution | Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062425 | LIFECATH S PICC AND MIDLINE CATHETER Vygon Corp., Sep 15, 2006 |