Palindrome Precision SI Hemodialysis Catheter Recall Due to Potential Packaging Breach
Mozarc Medical is recalling Palindrome Precision SI hemodialysis catheters due to a potential breach in sterile barrier packaging that could allow device 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: This is an FDA Class II recall of a sterile medical device. While the sterile barrier breach poses a theoretical risk of contamination and infection, no hospitalizations, illnesses, or injuries have been reported in the source. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Approximately 95,938 units were distributed worldwide, including to the United States, Canada, and Mexico.
The recall is due to a potential breach of the sterile barrier packaging. A compromised sterile barrier could allow bacterial contamination of the catheter, which poses an infection risk during use.
Individuals who may have been affected should consult with their healthcare provider or contact the manufacturer regarding specific units involved. Detailed information on model numbers, serial numbers, and unique device identifiers for affected units is available in the official FDA recall notice.
The recalled product
- Product
- Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Hazard
- sterile-barrier-breach
- contamination
- infection
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.8888133508P
- 8888123408P
- 8888119368P
- 8888128458P
- UDI: 20884521157931
- 20884521157795
- 20884521157726
- 20884521157863
- Serial No. 2234800132
- 2302500141
- 2302500148
- 2305300142
- 2305300144
- 2305300177
- 2313800083
- 2324100168
- 2324100310
- 2324100311
- 2405800229
- 2426300218
Distribution
Distributed nationwide across the United States.
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