Palindrome Precision H Chronic Hemodialysis Catheter Recalled for Sterile Barrier Packaging Defect
Mozarc Medical is recalling approximately 95,938 Palindrome Precision H Chronic Hemodialysis Catheters due to a potential breach in sterile barrier packaging. The breach could expose catheters to contamination.
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: Class II medical device recall involving a potential sterile barrier breach that presents contamination risk. No illnesses or injuries reported in source material. Meets High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Mozarc Medical US LLC is recalling approximately 95,938 units of the Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. These catheters are distributed nationwide in the United States and in Canada and Mexico. The recall involves multiple model numbers and associated lot/serial numbers.
The catheters are being recalled due to a potential breach in the sterile barrier packaging. A sterile barrier breach could allow contamination of the catheter.
Healthcare facilities and patients should contact Mozarc Medical US LLC or refer to the FDA recall notice (Z-1888-2025) for information about their affected units. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Hazard
- sterile-barrier-breach
- contamination-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.8888123405P
- 8888123411P
- 8888128455P
- 8888128461P
- 8888119365P
- 8888119371P
- 8888133505P
- UDI: 20884521157788
- 20884521157825
- 20884521157856
- 20884521157894
- 20884521157719
- 10884521157750
- 20884521157924
- Lot/Serial No. 2204000102
- 2228000068
- 2228000070
- 2234800148
- 2234800159
- 2234800160
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03