ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Reported: June 12, 2019 Initiated: January 17, 2017 #Z-1230-2019
Product Description
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
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.
Details
- Recalling Firm
- OriGen Biomedical, Inc.
- Units Affected
- 145
- 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
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F. Recalled by OriGen Biomedical, Inc.. Units affected: 145.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Critical. Recall number: Z-1230-2019.
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