Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack recalled
Mozarc Medical is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. The affected catheter models were distributed nationwide in the US and in Canada and Mexico.
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: This is an FDA Class II recall of a high-risk device (hemodialysis catheter) where a sterile barrier breach creates a risk of infection or harm. No illnesses or injuries are reported in the source text, and the hazard is the potential for contamination rather than confirmed harm, placing this at High (score 3) per the rubric.
Plain-English summary
Mozarc Medical US LLC is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack (radiopaque urethane catheters) due to a potential breach of sterile barrier packaging. The recall affects 95,938 units distributed worldwide, including US nationwide distribution and distribution to Canada and Mexico.
Affected model numbers include 8888123405P, 8888123411P, 8888128455P, 8888128461P, 8888119365P, 8888119371P, and 8888133505P. Multiple lot and serial numbers are involved in this recall.
Consumers or healthcare providers who have these catheters in stock should stop using them and contact Mozarc Medical US LLC for instructions on return or replacement. A breach of sterile barrier packaging may compromise the sterility of the device.
The recalled product
- Product
- Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Affected units
- 95,938
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.
Part of a larger recall action
This product is one of 5 recalled by Mozarc Medical US LLC 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.
See all 5 products in this recall →Related recalls
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