MAHURKAR Chronic Hemodialysis Catheter recalled for sterile barrier packaging breach
Mozarc Medical US LLC is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack due to a potential breach of sterile barrier packaging. The breach could allow contamination of the catheter, creating infection risk.
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: FDA Class II medical device recall involving a high-risk product (hemodialysis catheter) with potential for serious infection if sterile barrier is compromised. No reported injuries or deaths are documented; the hazard represents a recognized risk to patient safety but has not yet caused reported harm.
Plain-English summary
Mozarc Medical US LLC is recalling the MAHURKAR Chronic Hemodialysis Catheter Sport Pack, a radiopaque urethane catheter used for chronic hemodialysis. Approximately 95,938 units have been distributed worldwide, including 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 contamination of the catheter, creating a risk of infection when the device is used for vascular access in hemodialysis treatment.
The affected product includes Model No. 8888133502, UDI A8845210569201, and Lot/Serial No. 241760200. Patients and healthcare facilities should verify whether they have inventory or are currently using this specific lot and contact Mozarc Medical US LLC for further guidance.
The recalled product
- Product
- MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Hazard
- sterile-barrier-breach
- infection-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 (3)
- Model No.8888133502
- UDI: A8845210569201
- Lot/Serial No. 241760200.
Distribution
Distributed nationwide across the United States.
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