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U.S. Department of Health and Human Services

Class 2 Device Recall SERFAS Energy Suction Probe

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  Class 2 Device Recall SERFAS Energy Suction Probe see related information
Date Initiated by Firm April 26, 2007
Date Posted January 17, 2008
Recall Status1 Terminated 3 on January 16, 2008
Recall Number Z-0484-2008
Recall Event ID 45822
510(K)Number K041810  
Product Classification Electrosurgical Cutting Device - Product Code GEI
Product SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
Code Information Lot Numbers: 06361AE2 06362AE2 07004AE2 07008AE2 07010AE2 07012AE2 07016AE2 07017AE2 07018AE2 07022AE2 07025AE2 07026AE2 07029AE2 07031AE2 07036AE2 07038AE2 07043AE2, and  07044AE2  
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
408-754-2124
Manufacturer 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)
FDA Determined
Cause 2		 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 in Commerce 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 Scandinavia area), Australia, Canada, France, Germany, Greece, South Africa, Iberia, Italy, Mexico, Portugal, Switzerland (2 separate sites), and The UK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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