CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack recalled
Mozarc Medical US is recalling Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack, distributed nationwide in the US. The recall was initiated on 23 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1886-2025
- FDA event ID
- 96809
- Recalling firm
- Mozarc Medical US, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2025
- FDA classified
- 30 May 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 23 Apr 2025 | Recall initiated by company | |
| 30 May 2025 | Classified by FDA | +37 days |
| 11 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential breach of sterile barrier packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Questions about this recall
Is Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack recalled?
Yes. Mozarc Medical US recalled Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack on 23 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1886-2025.
Why was it recalled?
Potential breach of sterile barrier packaging.
Which lots are affected?
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, 2302500156, 2302500158, 2305300130, 2318500118, 2318500120, 2318500143, 2330300100, 2330300102, 2332700278, 2332700279, 2335200415, 2335200416, 2402400082, 2402400083, 2402400084, 2405800231, 2418000151, 2424200129, 2426300194, 2427700220.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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