Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns
Teleflex Medical is recalling OnControl Biopsy System Ported Needle 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 is classified as FDA Class II and involves a sterile medical device with a potential seal defect, which poses a risk of harm (infection) even though no injuries have been reported.
Plain-English summary
Teleflex Medical is recalling the OnControl Biopsy System Ported Needle Tray, Sterile, Rx only. The recall is due to a potential incomplete seal on the outer sterile package.
The affected product is the OnControl Biopsy System Ported Needle Tray, Material # 9470-VC-006, with lot numbers 010859 and 011511. The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients, while the Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients.
The product was distributed worldwide, including nationwide in the US and internationally to Brazil, Canada, Ecuador, Guatemala, Mexico, and Peru. The source text does not specify the number of units recalled or report any illnesses or injuries.
The recalled product
- Product
- OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, 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…
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Biopsy System
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 (2)
- Material # 9470-VC-006
- Lot numbers: 010859 & 011511.
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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