Z-1817-2017 Class II Terminated

Recalled by Micromedics, Inc. — Saint Paul, MN

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