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U.S. Department of Health and Human Services

Class 2 Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps

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  Class 2 Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps see related information
Date Initiated by Firm May 15, 2006
Date Posted June 27, 2006
Recall Status1 Terminated 3 on January 12, 2007
Recall Number Z-1175-06
Recall Event ID 35477
510(K)Number K020585  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
Code Information Catalog No. 2103PK and 917015PK all production codes
Recalling Firm/
Manufacturer
Gyrus Medical, Inc.
6655 Wedgewood Road
Suite 105
Maple Grove MN 55311
For Additional Information Contact Customer Service
800-852-9361
Manufacturer Reason
for Recall
Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
FDA Determined
Cause 2
Other
Action US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.
Quantity in Commerce 2971 (2931 domestic, 40 OUS)
Distribution Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV).
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 = GYRUS MEDICAL, INC.
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