Recall Z-1817-2017— Micromedics, Inc.
Class II · Terminated
Class II FDA medical device recall by Micromedics, Inc., initiated 2016-10-20, terminated 2019-07-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide. 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..
- Recalling firm
- Micromedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-20
- Terminated
- 2019-07-23
- Firm location
- Saint Paul, MN, United States
Product description
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.