FDAFDA · Food and drugs·Recall number Z-1817-2017
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Published April 19, 2017 · Recall initiated: October 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micromedics, Inc.
- Distributor
- AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
- Lot
- Lot Number: 163010 Expiration date: June 2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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