Recall Z-0678-2017 ยท KNW Instrument, Biopsy
Teleflex Medical
OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
| Date | Nov 8, 2016 |
| Status | Terminated |
| Reason | Sterility: Due to a potential incomplete seal on the outer sterile package. |
| Root cause | Device Design |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated November 8, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product, complete the enclosed Recall Acknowledgement Form and fax to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142377 | The OnControl Bone Marrow Biopsy System by Vidacare Vidacare, LLC, Dec 17, 2014 |