Recall Z-1817-2017 ยท KGZ Accessories, Catheter
Micromedics, Inc.
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
| Date | Oct 20, 2016 |
| 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.