ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, 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
Reported: December 7, 2016 Initiated: November 8, 2016 #Z-0675-2017
Product Description
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, 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 for Recall
Sterility: Due to a potential incomplete seal on the outer sterile package.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 113,647 units
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, 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. Recalled by Teleflex Medical. Units affected: 113,647 units.
Why was this product recalled? ▼
Sterility: Due to a potential incomplete seal on the outer sterile package.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0675-2017.
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