FDA Device

SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico

Hazard

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)

What You Should Do

Remedy

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.

Products

SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
Brand
Stryker Endoscopy
UPC
Lot Numbers: 06361AE2 06362AE2 07004AE2 07008AE2 07010AE2 07012AE2 07016AE2 07017AE2 07018AE2 07022AE2 07025AE2 07026AE2 07029AE2 07031AE2 07036AE2 07038AE2 07043AE2, and  07044AE2

Units Affected

6,037 units