Recall Z-0484-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
| Date | Jan 17, 2008 (initiated Apr 26, 2007) |
| Status | Terminated |
| Reason | 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) |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 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, WA, WI, WY, and WV; INTERNATIONAL: Affiliated Stryker Distribution Companies: Sweden (for Scandinav |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041810 | SERFAS ENERGY SYSTEM Stryker Endoscopy, Dec 21, 2004 |