Z-0102-2019 Class II Terminated
FDA device recall Z-0102-2019 was initiated by OriGen Biomedical, Inc. on August 21, 2018 and is designated Class II. Reason for recall: The catheter failed the endotoxin testing. The recall status is terminated (terminated October 5, 2021). Affected quantity: 106.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- August 21, 2018
- Termination Date
- October 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106
Product Description
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Reason for Recall
The catheter failed the endotoxin testing.
Distribution Pattern
US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand
Code Information
UDI: 00816203022059, lot N18687-1