Recall Z-1230-2019
OriGen Biomedical, Inc. · initiated January 17, 2017
Class I – dangerous or defective products that could cause serious health problems or death
Product
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Codes / lots: Lots: N18573, N18687-1
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.
FDA-determined 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.
Details
- Recall number
- Z-1230-2019
- Initiated
- January 17, 2017
- Posted by FDA
- June 4, 2019
- Terminated
- July 27, 2021
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 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
- Recalling firm
- OriGen Biomedical, Inc., Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1227-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1228-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1229-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1231-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1232-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |