FDA Medical Device Recalls (openFDA)
Micromedics, Inc.: Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
- Recall number
- Z-1817-2017
- Recalling firm
- Micromedics, Inc.
- Product
- Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
- Status
- Terminated
- Initiated
- 2016-10-20
- Posted
- not on file
- Terminated
- 2019-07-23
- 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.
- Root cause
- Employee error
- Action
- A Medical Device Recall Letter was sent to customers beginning 10/20/2016 via Federal Express in the US and via UPS ground in Israel. The letter identified the affected device and lot number, issue, asked for product to be discontinued from use, quarantine and notify Nordson Medical, via a response form. Response form can be faxed back at 888-504-0606, email to sharon.lynch@nordsonmedical.com or mailed to Nordson Medical, 1270 Eagan Industrial Road, Suite 120, St. Paul, MN 55121.
- Quantity
- 273 units
- Distribution
- AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
- Lot, serial or model codes
- Lot Number: 163010 Expiration date: June 2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGZ
- Firm FEI
- 2183425
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28