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U.S. Department of Health and Human Services

Class 2 Device Recall SOLTIVE Laser Fibers

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  Class 2 Device Recall SOLTIVE Laser Fibers see related information
Date Initiated by Firm May 26, 2022
Create Date June 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1296-2022
Recall Event ID 90338
510(K)Number K183647  
Product Classification Powered laser surgical instrument - Product Code GEX
Product SOLTIVE SuperPulsed Laser Fibers,
Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber
Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber
Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber
Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber
Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber
Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber
Code Information UDI-DI Lot Model# Labeled  00821925043923 KR149856 TFL-FBX150BS (Carton) 00821925043923 KR149856 TFL-FBX200S (Pouch) 00821925043985 KR195775 TFL-FBX200BS (Carton)  00821925044043 KR197789 TFL-FBX550S (Carton)  00821925043930 KR206254 TFL-FBX200S (Carton)  00821925043930 KR206254 TFL-FBX365S (Pouch)
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
484-896-5000
Manufacturer Reason
for Recall		 Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
FDA Determined
Cause 2		 Labeling mix-ups
Action Firm notified customers by letter on May 26, 2022. Customers were instructed to return on hand inventory to Olympus for credit.
Quantity in Commerce 190 cartons (950 pieces total)
Distribution Nationwide distribution in the US. Foreign distribution worldwide.
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 = GEX and Original Applicant = Olympus Surgical Technologies America
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