Recall Z-1227-2019 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
| Date | Jun 4, 2019 (initiated Jan 17, 2017) |
| Status | Terminated |
| Reason | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. |
| Root cause | Process control |
| Action | On 01/17/2017, Technical Bulletin 17.01 was mailed to customers. Customers were informed to clamp all sizes of catheters only in the middle. The following contact information was provided: US: 1-512-474-7278, and Germany: +49-7475-915591. |
| Quantity | 260 |
| Distribution | US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland |
| 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 |