Nordson Micromedics FibriJet Endoscopic Catheter Introducer — Class II medical device recall Z-1817-2017
Terminated recall by Micromedics, Inc., reported 2017-04-19, distributed in AL, CA, FL, MS, NC, NJ, NY, TN…. The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the pa
| Recall number | Z-1817-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micromedics, Inc., Saint Paul, MN, United States |
| Recall initiated | 2016-10-20 |
| Classified | 2017-04-12 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-07-23 |
| Distributed | AL, CA, FL, MS, NC, NJ, NY, TN, TX |
| Countries outside the US | IL |
| Quantity | 273 units |
| Reason classes | sterility, packaging |
| Lot numbers | 163010 |
| Model numbers | SA-3445 |
| Expiration dates | 2021-06-20 |
Product
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1817-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.