FDA Enforcement
Class II
Terminated
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
Recall: Z-0678-2017
·
Reported December 7, 2016
Enforcement
- Recall Number
- Z-0678-2017
- Event ID
- 75637
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Teleflex Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 7, 2016
- Initiation Date
- November 8, 2016
- Classification Date
- November 30, 2016
- Termination Date
- November 20, 2019
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States
Description
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
Reason
Sterility: Due to a potential incomplete seal on the outer sterile package.
Code Info
Material # 9470-VC-006, Lot numbers: 010859 & 011511.
Distribution
Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.