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U.S. Department of Health and Human Services

Class 1 Device Recall Olympus Single Use Guide Sheath Kits

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 Class 1 Device Recall Olympus Single Use Guide Sheath Kitssee related information
Date Initiated by FirmJanuary 15, 2025
Date PostedFebruary 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1071-2025
Recall Event ID 96087
510(K)NumberK060243 
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductOlympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
Code Information 1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3. Model Number: K-203; UDI-DI: 04953170245503; All Lots 4. Model Number: K-204; UDI-DI: 04953170245527; All Lots
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus notified consignees on about 01/15/2024, via letter. Consignees were instructed to examine inventory and quarantine affected devices, cease usage of the product immediately, acknowledge receipt of the letter through the Olympus web portal, and to forward the notice to all applicable personnel and customers if further distributed.
Quantity in Commerce454 units
DistributionUS nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EOQ
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