Palindrome Precision HSI Hemodialysis Catheter Recalled for Sterile Barrier Breach
Mozarc Medical is recalling the Palindrome Precision HSI Chronic Hemodialysis Catheter due to potential breaches in sterile barrier packaging. Affected units may pose infection risk if the barrier has been compromised.
What this means for you
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: This is classified as a risk-of-harm product where injury has not yet been reported. A breach in the sterile barrier of a hemodialysis catheter creates a potential for serious infection, which is a significant clinical risk, even though no illnesses have been reported at this time.
Plain-English summary
The Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack is being recalled by Mozarc Medical US LLC due to a potential breach of the sterile barrier packaging. This is a radiopaque urethane catheter used in chronic hemodialysis treatment.
The sterile barrier packaging is critical to maintaining the sterility of the device prior to use. A breach in this packaging could compromise the sterile condition of the catheter, potentially exposing it to contamination and increasing the risk of serious infection for patients who use the device.
Approximately 95,938 units have been distributed nationwide in the United States, as well as in Canada and Mexico. The recall affects units with specific lot and model numbers, detailed on the FDA website.
Patients and healthcare providers should discontinue use of affected units if they have the specified model and lot numbers. Consult with your healthcare provider regarding alternative dialysis catheter options and proper disposal of recalled units.
The recalled product
- Product
- Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Hazard
- sterile-barrier-breach
- infection-risk
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)
- Model No.8888128459P
- 8888119369P
- 8888133509P
- 8888123409P
- UDI: 20884521157870
- 20884521157733
- 20884521157948
- 20884521157801
- Lot/Serial No. 2133600044
- 2201700104
- 2203300067
- 2228000065
- 2228000067
- 2228000077
- 2234800091
- 2234800133
- 2234800161
- 2301100103
- 2302500152
- 2302500153
Distribution
Distributed nationwide across the United States.
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