Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXV
FDA device recall Z-1146-2013 · posted 2013-04-18 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
- Action taken
- The firm initiated a recall in Europe via customer letters starting January 30, 2013 to notify the recall of model number T001691A lot number 59326333. The recall was expanded and a worldwide recall via customer letters was initiated on February 11, 2013. The letter identified the product, problem, and actions to be taken by the customers.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 30,467
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI) and Europe.
- Date initiated
- 2013-01-30
- Date posted
- 2013-04-18
- Date terminated
- 2016-03-10
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 (K925638) | Baxter Healthcare Corp | 1993-10-18 |
| VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION (K896819) | Baxter Healthcare Corp | 1990-01-19 |