Z-1232-2019 Class I Terminated
FDA device recall Z-1232-2019 was initiated by OriGen Biomedical, Inc. on January 17, 2017 and is designated Class I. 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 … The recall status is terminated (terminated July 27, 2021). Affected quantity: 66.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- January 17, 2017
- Termination Date
- July 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66
Product Description
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
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 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
Code Information
Lots: N18487, N18487-1, N18561-1, R19169