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
FDA Recall Z-0678-2017 · Posted None
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKNW
Date Initiated2016-11-08
Date Terminated2019-11-20
Reason for Recall
Sterility: Due to a potential incomplete seal on the outer sterile package.
Firm 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 [email protected]. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990.
For questions regarding this recall call 919-433-4940.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.