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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 Recall
SERFAS Energy Suction Probe
see related information
Date Posted January 17, 2008
Recall Status1 Terminated on January 16, 2008
Recall Number Z-0484-2008
Recall Event ID 45822
Premarket Notification
510(K) Number
K041810 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - 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, California 95138
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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