MAHURKAR Chronic Hemodialysis Catheter recalled for sterile barrier defect
Mozarc Medical is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack units due to a potential breach in sterile barrier packaging that could compromise the product's sterility.
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 involving a sterile barrier breach on a medical device used for critical medical procedures. Although no illnesses or injuries have been reported, the potential for infection from compromised sterility on a device inserted into the bloodstream poses a significant risk of serious harm.
Plain-English summary
Mozarc Medical US LLC is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack, a radiopaque urethane catheter used in chronic hemodialysis. The recall affects approximately 95,938 units distributed worldwide, including nationwide in the US and in Canada and Mexico. Model No. 8888133502 with UDI A8845210569201 and Lot/Serial No. 241760200 are involved.
The products are being recalled due to a potential breach of the sterile barrier packaging. This breach could affect the sterility of the catheter, creating a risk of infection or other complications when used for hemodialysis treatment.
Patients and healthcare providers who have these catheters should discontinue use and contact Mozarc Medical US LLC for instructions on how to return or dispose of the affected units safely.
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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