ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
- Company
- Origen Biomedical, Inc.
- Recall Initiated
- January 17, 2017
- Posted
- June 4, 2019
- Terminated
- July 27, 2021
- Recall Number
- Z-1230-2019
- Quantity
- 145
- Firm Location
- Austin, TX
Reason for Recall
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.
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, South Africa, Chile
Lot / Code Info
Lots: N18573, N18687-1
Root Cause
Process control
Action Taken
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.