Z-1817-2017 Class II Terminated
FDA device recall Z-1817-2017 was initiated by Micromedics, Inc. on October 20, 2016 and is designated Class II. 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. The recall status is terminated (terminated July 23, 2019). Affected quantity: 273 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- October 20, 2016
- Termination Date
- July 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 273 units
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.
Distribution Pattern
AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
Code Information
Lot Number: 163010 Expiration date: June 2021