Palindrome Precision SI Chronic Hemodialysis Catheter Sterile Barrier Recall
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.
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 medical device recall involving a sterile barrier breach—a risk-of-harm hazard for infection in hemodialysis patients. No reported illnesses or injuries are stated in the source, so the score is at most 3 per the rubric.
Plain-English summary
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack), radiopaque urethane catheters used for chronic hemodialysis. The recall was initiated due to a potential breach of sterile barrier packaging.
Approximately 95,938 units have been distributed worldwide, including throughout the United States, Canada, and Mexico. The affected catheters are identified by Model Numbers 8888133508P, 8888123408P, 8888119368P, and 8888128458P, along with specific serial numbers and UDI codes documented in the recall notice.
A compromised sterile barrier could potentially allow microbial contamination of the device, which could lead to serious infections in patients who rely on these catheters for hemodialysis treatment. Consumers and healthcare providers who have received affected units should contact Mozarc Medical US LLC or refer to the FDA recall notice for instructions on product return or replacement.
The recalled product
- Product
- Palindrome Precision SI 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.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.
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.
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