PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distribut
FDA device recall Z-1022-2011 · posted 2011-02-02 · Terminated
Recall details
- Recalling firm
- Peak Surgical
- Reason for recall
- A customer reported that a patient suffered a burn while using the device.
- Action taken
- Peak Surgical notified afftected customers by phone on May 19, 2009. They were notified of the product, the problem, and the action to be taken. Peak Surgical sales representatives removed PlasmaBlade EXT devices from consignees affected by the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 493 units
- Distribution
- Worldwide Distribution - United States including CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, and WAand the countries of Turkey and Ireland
- Date initiated
- 2009-05-19
- Date posted
- 2011-02-02
- Date terminated
- 2011-04-21
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES (K082786) | Peak Surgical, Inc. | 2008-12-03 |