Recall Z-2197-2018 ยท DYB Introducer, Catheter
Angiodynamics Inc. (Navilyst Medical Inc.)
Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
| 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 | 86 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
| K000313 | TEARAWAY INTRODUCER SHEATH Xentek Medical, Inc., Jun 16, 2000 |