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U.S. Department of Health and Human Services

Class 2 Device Recall ABC PROBE, 160636

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  Class 2 Device Recall ABC PROBE, 160636 see related information
Date Initiated by Firm December 18, 2008
Date Posted August 25, 2010
Recall Status1 Terminated 3 on October 22, 2010
Recall Number Z-2280-2010
Recall Event ID 52030
510(K)Number K925903  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502 ASSEMBLED IN MEXICO

ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO

Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
Code Information Lot: 0306021 through 0806021
Recalling Firm/
Manufacturer
ConMed Electrosurgery
14603 E Fremont Ave
Centennial CO 80112-4251
For Additional Information Contact
303-269-8824
Manufacturer Reason
for Recall
The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.
FDA Determined
Cause 2
Process design
Action An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.
Quantity in Commerce Dom: 184 cs (1840 units); Int'l: 47 cs (470 units)
Distribution Nationwide and International
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 = BIRTCHER MEDICAL SYSTEMS, INC.
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