Teleflex Medical recalls OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is inten

Recalled December 7, 2016 · FDA recall Z-0678-2017 · Teleflex Medical

Hazard

Sterility: Due to a potential incomplete seal on the outer sterile package. · FDA Class II

Sold at

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

Description

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

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

Manufacturer(s)

Teleflex Medical

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →