Device 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
Z-0678-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 75637
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0678-2017
Official wording
Reason: Sterility: Due to a potential incomplete seal on the outer sterile package.
Code information: Material # 9470-VC-006, Lot numbers: 010859 & 011511.
Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
incomplete seal on the outer sterile package