—#150972

Product

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 product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K142377
Affected lot / code info: Material # 9470-VC-006, Lot numbers: 010859 & 011511.

Why it was recalled

Sterility: Due to a potential incomplete seal on the outer sterile package.

Root cause (FDA determination)

Device Design

Action the firm took

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 call 919-433-4940.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.

Timeline

Recall initiated: 2016-11-08
Terminated: 2019-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.