Recall Z-0102-2019
OriGen Biomedical, Inc. · initiated August 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Codes / lots: UDI: 00816203022059, lot N18687-1
Reason for recall
The catheter failed the endotoxin testing.
FDA-determined cause: Release of Material/Component prior to receiving test results
Action taken
On 08/21/18, the firm emailed a recall notice to customers informing them of a nationwide recall of RDLC ECMO catheters. Customers were advised to return affected product to the firm. Customers with additional questions were advised to call 1-800-233-9014 or 1-512-474-7278. The firm also sent customers Technical Bulletin (TB) 1411 - Revision Feb 2018, Subject: Radiopacity of the Reinforced Dual Lumen Catheter (RDLC), Date: July 2015, and an Acknowledgment Receipt form to complete and return. On 09/12/18, and 09/20/18, the firm sent two additional recall notices, which included additional affected lot numbers that were not the subject of the current removal.
Details
- Recall number
- Z-0102-2019
- Initiated
- August 21, 2018
- Terminated
- October 5, 2021
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 106
- Distribution
- 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
- Recalling firm
- OriGen Biomedical, Inc., Austin, TX