| Class 2 Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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