Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack Recalled
Mozarc Medical is recalling Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Packs due to a potential breach of sterile barrier packaging that could compromise the catheter'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 of a sterile medical device with a potential breach of sterile barrier packaging—a risk-of-harm condition for a chronic use catheter that could lead to serious infection. The source text does not report any illnesses or injuries, so the score is 3 under the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mozarc Medical US LLC is recalling Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Packs distributed worldwide, including in the US, Canada, and Mexico. The radiopaque urethane catheters are being recalled due to a potential breach of the sterile barrier packaging.
A compromised sterile barrier could allow contamination of the catheter, which is intended for use in chronic hemodialysis treatment. This could place patients at risk of infection or other adverse effects during use.
Patients and healthcare providers who have affected catheters should not use them. Affected lot and serial numbers are listed in the recall notice. Consumers with questions should contact their healthcare provider or the manufacturer for instructions on obtaining replacement products or further guidance.
The recalled product
- Product
- Palindrome Precision HSI 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.8888128459P
- 8888119369P
- 8888133509P
- 8888123409P
- UDI: 20884521157870
- 20884521157733
- 20884521157948
- 20884521157801
- Lot/Serial No. 2133600044
- 2201700104
- 2203300067
- 2228000065
- 2228000067
- 2228000077
- 2234800091
- 2234800133
- 2234800161
- 2301100103
- 2302500152
- 2302500153
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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