Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Pro

FDA device recall Z-1374-2021 · posted 2021-04-07 · Open, Classified

Recall details

Recalling firm

Arrow International Inc

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

Action taken

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

Root cause

Process design

Status

Open, Classified

Product code

KNW

Quantity affected

3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS

Distribution

US Nationwide distribution.

Date initiated

2021-03-08

Date posted

2021-04-07

Location

Reading, PA

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