Recall Z-1817-2017
Micromedics, Inc. · initiated October 20, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Codes / lots: Lot Number: 163010 Expiration date: June 2021
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-1817-2017
- Initiated
- October 20, 2016
- Terminated
- July 23, 2019
- Product code
- KGZ – Accessories, Catheter
- Quantity
- 273 units
- Distribution
- AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
- Recalling firm
- Micromedics, Inc., Saint Paul, MN