FDAFDA · Food and drugs·Recall number Z-1232-2019
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Published June 12, 2019 · Recall initiated: January 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- OriGen Biomedical, Inc.
- Distributor
- 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
- Lots: N18487, N18487-1, N18561-1, R19169
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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