Recall Z-0269-2019 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
OriGen Biomedical, Inc.
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
| Date | Nov 7, 2018 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage |
| Root cause | Mixed-up of materials/components |
| Action | On April 1, 2015 the firm sent an MEDICAL DEVICE MARKET WITHDRAWAL to customers/distributors via email to inform them the catheters may start to show signs of failure at the junction of the clear extension tube and blue hub connection that can be recognized by air entrainment or blood leakage. If the preliminary failure is identified, the catheter should be replaced immediately. Serious injuries could occur due to the failure mode. The customers are instructed to discontinue use of all products from the affected lot and to return any unused products immediately and to complete and return th |
| Quantity | 134 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER Origen Biomedical, Inc., Jul 26, 2012 |