FDA Device recall Z-2197-2018
Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 by Angiodynamics Navilyst Medical, citing A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2197-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-10 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | 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, WV |
Product
Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
Reason
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Identifiers
| code_info | UPN: H965459011; Lot: G18012001, G18064125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2197-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.