ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
FDA device recall Z-1227-2019 · posted 2019-06-04 · Terminated
Recall details
- Recalling firm
- OriGen Biomedical, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 260
- 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, Netherla
- Date initiated
- 2017-01-17
- Date posted
- 2019-06-04
- Date terminated
- 2021-07-27
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORIGEN REINFORCED DUAL LUMEN CATHETER (K113869) | Origen Biomedical, Inc. | 2012-07-26 |