FDA Device recall Z-1817-2017
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445 by Micromedics, citing the sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assuran….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1817-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-20 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Micromedics |
| Distribution | AL, CA, FL, MS, NC, NJ, NY, TN, TX |
Product
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Reason
The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.
Identifiers
| code_info | Lot Number: 163010 Expiration date: June 2021 |
|---|
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-1817-2017%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.