Teleflex Recalls Arrow OnControl Bone Marrow Biopsy System Trays
Teleflex Medical is recalling 113,647 units of Arrow OnControl Bone Marrow Biopsy System Trays due to a potential incomplete seal on the outer sterile package.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential incomplete seal on the sterile package, which is a low-risk contamination or packaging issue without reported illnesses or injuries.
Plain-English summary
Teleflex Medical is recalling 113,647 units of the ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only. The recall is due to a potential incomplete seal on the outer sterile package.
The affected products are intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients. The recall includes Material # 9408-VC-006 and Material #9411-VC-006 across various lot numbers.
The products were distributed nationwide in the United States and internationally to Brazil, Canada, Ecuador, Guatemala, Mexico, and Peru. Healthcare providers should stop using the affected lots and contact Teleflex Medical for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Teleflex Medical
- Affected units
- 113,647
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 # 9408-VC-006
- Lot numbers: 010256
- 010257
- 010438
- 010439
- 010556
- 010557
- 010737
- 010738
- 010739
- 010946
- 010947
- 011037
- 011046
- 011047
- 011048
- 011215
- 011216
- 011217
- 011380
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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