Teleflex Recalls Arrow OnControl Aspiration System Trays Due to Sterility Concerns
Teleflex Medical is recalling specific lots of Arrow OnControl Ported Aspiration System Trays because the outer sterile package may have an incomplete seal.
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 the hazard involves a potential loss of sterility in a medical device used for invasive procedures, which presents a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Teleflex Medical is recalling specific lots of the Arrow OnControl Ported Aspiration System Tray, Sterile, Rx only. The recall is due to a potential incomplete seal on the outer sterile package. The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients, while the Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients.
The affected products include Material # 9471-VC-006 (Lot numbers: 013107, 013260, 013889, 014126 & 014324), Material # 9472-VC-006 (Lot numbers: 013108 & 013261), and Material # 9403-VC-006 (Lot numbers: 010848, 011230, 011587, 012101, 012348, 012697, 013245, 013888, 014127, 014208 & 014407). These products were distributed nationwide in the US and internationally to Brazil, Canada, Ecuador, Guatemala, Mexico, and Peru.
Healthcare providers and facilities should stop using the affected lots and contact Teleflex Medical for instructions on how to return or dispose of the products. Patients who have already received treatment with these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- ARROW OnControl Ported Aspiration System 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
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 (18)
- Material # 9471-VC-006
- Lot numbers: 013107
- 013260
- 013889
- 014126 & 014324
- Material # 9472-VC-006
- Lot numbers: 013108 & 013261
- Material # 9403-VC-006
- Lot numbers: 010848
- 011230
- 011587
- 012101
- 012348
- 012697
- 013245
- 013888
- 014127
- 014208 & 014407.
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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