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Recall Observatory FDA recall evidence

Device product

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

Z-1230-2019

January 17, 2017

Class I

Product summary

Firm
OriGen Biomedical, Inc.
Event
Event 82512
Status
Terminated
Classification
Class I
Quantity
145
Official record key
device-enforcement:Z-1230-2019

Official wording

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.

Code information: Lots: N18573, N18687-1

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.