Palindrome Precision Chronic Hemodialysis Catheter Sport Pack Recalled
Mozarc Medical US LLC is recalling Palindrome Precision Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. Affected units were distributed worldwide including the US, Canada, and Mexico.
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 medical device with potential for serious harm (sterile barrier breach in a hemodialysis catheter poses infection risk), but no reported illnesses or injuries are stated in the source text. Per the rubric, a Class II with no reported harm and theoretical risk-of-harm is scored at 3 (High).
Plain-English summary
Mozarc Medical US LLC is recalling Palindrome Precision Chronic Hemodialysis Catheter Sport Pack (a radiopaque urethane catheter) due to a potential breach of sterile barrier packaging. Approximately 95,938 units have been distributed.
The affected products were distributed worldwide, including nationwide distribution in the United States and in Canada and Mexico. Multiple model numbers, lot/serial numbers, and UDI codes are involved in this recall.
Patients and healthcare providers should contact their supplier or Mozarc Medical US LLC regarding the recalled units. A compromised sterile barrier could affect the sterility of the catheter prior to use.
The recalled product
- Product
- Palindrome Precision 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. 8888128450P
- 8888123404P
- 8888123410P
- 8888128454P
- 8888128460P
- 8888133500P
- 8888133504P
- 8888133510P
- 8888123400P
- 8888119360P
- 8888119370P
- 8888119364P
- UDI: A8845211578301
- A8845211577701
- A8845211578101
- A8845211578401
- A8845211578801
- A8845211579001
- A8845211579101
- 20884521157955
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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