Class II — Micromedics, Inc.
| Recalling firm | Micromedics, Inc. |
|---|---|
| Registered facility | MICROMEDICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide |
| Quantity | 273 units |
| Distribution | AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel |
| Initiated | 2016-10-20 |
| Classified | 2017-04-12 |
| Terminated | 2019-07-23 |
| Recall number | Z-1817-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Micromedics, Inc. (Z-1817-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75890/
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