ARROW OnControl Ported Aspiration System Tray recall: Sterility Concern
ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow…
Why was ARROW OnControl Ported Aspiration System Tray recalled?
Sterility: Due to a potential incomplete seal on the outer sterile package.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material # 9471-VC-006, Lot numbers: 013107, 013260, 013889, 014126 & 014324; Material # 9472-VC-006, Lot numbers: 013108 & 013261; Material # 9403-VC-006, Lot numbers: 010848, 011230, 011587, 012101, 012348, 012697, 013245, 013888, 014127, 014208 & 014407.
- Product
- ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow…
- Recalling firm
- Teleflex Medical
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)