SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
FDA device recall Z-0484-2008 · posted 2008-01-17 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)
- Action taken
- Consignees were mailed an Urgent Device Removal Recall notice, dated April 27, 2007. International subsidiaries will receive the recall notice and they will distribute to their consignees. Product is to be returned as a recall.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 6,037 units
- Distribution
- Worldwide Distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA,
- Date initiated
- 2007-04-26
- Date posted
- 2008-01-17
- Date terminated
- 2008-01-16
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERFAS ENERGY SYSTEM (K041810) | Stryker Endoscopy | 2004-12-21 |