Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns
Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterility failure in a medical device used for invasive procedures, which poses a risk of infection. No specific injuries or illnesses are reported in the source text, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling the ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, and the Arrow OnControl Bone Marrow Aspiration System. These medical devices are intended for bone marrow aspiration and core biopsy of the iliac crest in adult and pediatric patients.
The recall was initiated due to a potential incomplete seal on the outer sterile package. This defect may compromise the sterility of the devices.
The affected products were distributed nationwide in the United States and internationally to Brazil, Canada, Ecuador, Guatemala, Mexico, and Peru. The recall covers specific material numbers 9451-VC-006 and 9458-VC-006 across numerous lot numbers. Healthcare providers and facilities should stop using these devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, 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
- Manufacturer
- Teleflex Medical
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Material # 9451-VC-006
- Lot numbers: 010183
- 010560
- 010780
- 010951
- 010972
- 011042
- 011050
- 011348
- 011382
- 011583
- 011709
- 011952
- 012343
- 012568
- 012690
- 013071
- 013247
- 013470
- 013692
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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