Recall Z-2194-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
| Date | May 10, 2018 |
| Status | Terminated |
| Reason | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). |
| Root cause | Material/Component Contamination |
| Action | Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) 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 AngioDynamics, Inc. 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. If affected product is located in y |
| Quantity | 246 boxes |
| Distribution | The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142616 | PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc., Oct 14, 2014 |