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U.S. Department of Health and Human Services

Class 2 Device Recall BICOAG Hemostasis Probe

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  Class 2 Device Recall BICOAG Hemostasis Probe see related information
Date Initiated by Firm January 05, 2024
Date Posted April 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-1481-2024
Recall Event ID 94150
510(K)Number K123319  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Product Hemostasis Probe, Model: CD-B622LA
Code Information Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
FDA Determined
Cause 2		 Employee error
Action On January 30, 2024, the firm notified its only customer of the issue via URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION letters. Actions to be taken by the end user: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact your Regional Customer Service, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number "XXXX and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including mispackaging, to your Regional Complaint Intake Contact. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact your regional contact person.
Quantity in Commerce 36 units (all OUS)
Distribution International distribution only.
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 = KNS and Original Applicant = OLYMPUS SURGICAL TECHNOLOGIES AMERICA
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