CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
Mahurkar Chronic Hemodialysis Catheter Sport Pack recalled
Mozarc Medical US is recalling Mahurkar 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-1889-2025
- 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
MAHURKAR 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
Why was it recalled?
Potential breach of sterile barrier packaging.
Which lots are affected?
Model No.8888133502; UDI: A8845210569201; Lot/Serial No. 241760200.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96809This product is part of a recall event; the main page for the event is Palindrome Precision Chronic Hemodialysis Catheter Sport Pack recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack recalled | Mozarc Medical US | Sterility | Nationwide | |
| CLASS II | Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack recalled | Mozarc Medical US | Sterility | Nationwide | |
| CLASS II | Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack recalled | Mozarc Medical US | Sterility | Nationwide | |
| CLASS II | Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack recalled | Mozarc Medical US | Sterility | Nationwide |
More recalls from Mozarc Medical US
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mahurkar Elite PASS Trays recalled by Mozarc Medical US | Mozarc Medical US | Other | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |