Transonic ADT1018 Hemodialysis Tubing Recalled Due to Sterility Concerns
Transonic Systems Inc. is recalling ADT1018 Flow QC Clear Advantage Tubing because the sterility of the device cannot be assured, posing a potential risk of infection.
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. The hazard involves a risk of infection due to compromised sterility in a medical device used in an extracorporeal blood circuit, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Transonic Systems Inc. is recalling Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018 and ADT1018-40. The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.
The recall is being conducted because the sterility of the device cannot be assured. This condition creates a potential for an increased risk of infection for patients using the tubing.
The affected units are from Lots B151130E2 and B161115E0. A total of 6,044 units were distributed nationwide in the United States and to the states of NJ, NY, OH, PA, and TX. The products were also distributed to Canada, South Korea, Thailand, Australia, and Taiwan. Users should stop using the affected tubing and contact Transonic Systems Inc. for instructions on return or replacement.
The recalled product
- Product
- Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements…
- Manufacturer
- Transonic Systems Inc
- Affected units
- 6,044
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 (1)
- Lots B151130E2 and B161115E0
Distribution
Related recalls
Same manufacturer · Transonic Systems Inc
See all →- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect in EPROM
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighTransonic Hemodialysis Monitor Recall Due to Inaccurate Flow Measurements
FDA (Devices) · 2015-03-25
- HighTransonic AV Loop Kit Recalled for Blood Leakage Complaints
FDA (Devices) · 2013-04-24
- HighCook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
FDA (Devices) · 2019-11-27
- HighCook Torcon NB Advantage Catheters Recalled for Sterility Compromise
FDA (Devices) · 2019-11-27
- HighCook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Compromise
FDA (Devices) · 2019-11-27
- HighAspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
FDA (Devices) · 2014-04-16