—#186193

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.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K113872
Affected lot / code info: Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-03-08
Posted by FDA: 2021-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.