Agency classClass IIOur severity:High FDA (Devices)·Z-0677-2017·Announced 2016-12-07

Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays

Teleflex Medical is recalling Arrow OnControl Bone Lesion 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 3/5 (High).

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 harm, but no injuries or illnesses have been reported.

Plain-English summary

Teleflex Medical is recalling the Arrow OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only. The recall is due to a potential incomplete seal on the outer sterile package. The system is intended for bone biopsy of the vertebral body and bone lesions.

The affected products were distributed worldwide, including the United States, Brazil, Canada, Ecuador, Guatemala, Mexico, and Peru. The recall covers specific material numbers and lot numbers, including 9461-VC-001, 9461-VC-006, 9462-VC-001, 9462-VC-006, 9463-VC-001, 9463-VC-006, 9464-VC-001, 9464-VC-006, 9465-VC-001, 9465-VC-006, 9466-VC-001, and 9466-VC-006.

Healthcare providers should stop using the affected trays and contact Teleflex Medical for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Manufacturer: Teleflex Medical
Category: Medical Device — Surgical Instruments
Hazard: sterility-failure

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 # 9461-VC-001
Lot numbers: 012579S
013469S
011227 & 011492
Material # 9461-VC-006
011938
012694
013065
013686 & 014615
Material # 9462-VC-001
Lot numbers: 010743S
10778S
010954S
012580S & 012891S
Material # 9462-VC-006
Lot numbers: 010444
010743
010778
010954
011495

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.

See all 5 products in this recall →

Same manufacturer · Teleflex Medical

See all →

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Low
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Moderate
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High
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High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
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Same hazard · sterility failure