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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow OnControl Bone Lesion Biopsy System

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  Class 2 Device Recall Arrow OnControl Bone Lesion Biopsy System see related information
Date Initiated by Firm March 08, 2021
Date Posted April 07, 2021
Recall Status1 Open3, Classified
Recall Number Z-1374-2021
Recall Event ID 87499
510(K)Number K113872  
Product Classification Instrument, biopsy - Product Code KNW
Product Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)
Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
Code Information Lot Numbers US: 39647326 39647327 39647328 40422734 40422735  Lot Number: 40808740 (EU)  EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact SAME
610-378-0131
Manufacturer Reason
for Recall		 Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
FDA Determined
Cause 2		 Process design
Action Teleflex issued to US consignee notification letter on March 8, 2021 via FedEx 2-day mail. Letter states reason for recall, health risk, and action to take: Action list number 1  Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-Mail address mentioned below. 3. If you do have stock in scope of this FSCA, mark the according checkbox on the Acknowledgement Form (Appendix 1) and contact customer service by calling the phone number mentioned below. Customer service will issue you with a return number. Write the return number into the respective field in the Acknowledgement Form and return this form immediately to Customer Service. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2  Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the acknowledgement form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. 4. If you have further distributed product outside of your country, please notify Teleflex by return email to the e-Mail address below. Should you require any further information or support concerning this issue, please contact: Customer Service: Contact: Customer Serv
Quantity in Commerce 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
Distribution US Nationwide distribution.
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 = KNW and Original Applicant = VIDACARE CORPORATION
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