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U.S. Department of Health and Human Services

Class 2 Device Recall Roller Bar Electrode

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  Class 2 Device Recall Roller Bar Electrode see related information
Date Initiated by Firm October 02, 2023
Date Posted December 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-0568-2024
Recall Event ID 93417
510(K)Number K890328  
Product Classification Electrode, electrosurgical, active, urological - Product Code FAS
Product ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
Code Information UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact
484-896-5000
Manufacturer Reason
for Recall		 Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
FDA Determined
Cause 2		 Labeling Change Control
Action An Urgent Medical Device Recall notice, issued via UPS Ground October 27, 2023, advises customers of the mislabeled product pouches. Customers are to examine and quarantine any affected inventory, contact Olympus customer service to arrange for return/replacement, and forward notice to any facility where product was further distributed. Acknowledge receipt of the recall notice through the Olympus recall portal at https://olympusamerica.com/recall (enter recall number "0432"). Customers requiring additional information may contact Cynthia.Ow@olympus.com.
Quantity in Commerce 162 pieces (27 boxes, 6 per box)
Distribution US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FAS and Original Applicant = CIRCON VIDEO
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