CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Mahurkar Elite PASS Trays recalled by Mozarc Medical US
Mozarc Medical US is recalling Mahurkar Elite PASS Trays, distributed nationwide in the US. The recall was initiated on 29 Apr 2026 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-2319-2026
- FDA event ID
- 98891
- Recalling firm
- Mozarc Medical US, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Apr 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 29 Apr 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +37 days |
| 17 Jun 2026 | 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
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Product as listed by the FDA
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Which lots are affected?
1. Product Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038; 2. Product Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147; 3. Product Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032; 6. Product Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007; 7. Product Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042; 9. Product Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009; 10. Product Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054; 14. Product Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351, 251740196, 252020045, 252230022, 252580024; 15. Product Number (CFN): 8888231430; UDI-DI: 10884521788701; Lot number: 252730009; 16. Product Number (CFN): 8888231413; UDI-DI: 10884521788664; Lot number: 250310010; 17. Product Number (CFN): 8888231416; UDI-DI: 10884521788671; Lot numbers: 252230021, 252510030, 252650294, 253140280; 18. Product Number (CFN): 8888213416; UDI-DI: 10884521788527; Lot number: 252300325; 19. Product Number (CFN): 8888211416; UDI-DI: 10884521788435; Lot numbers: 241060237, 250830187, 250900067, 251250037, 251430012, 252870014; 20. Product Number (CFN): 8888213420; UDI-DI: 10884521788534; Lot number: 252300051; 21. Product Number (CFN): 8888211420; UDI-DI: 10884521788442; Lot numbers: 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034; 22. Product Number (CFN): 8888212413; UDI-DI: 10884521788473; Lot number: 242950260; 23. Product Number (CFN): 8888211413; UDI-DI: 10884521788428; Lot number: 252510028; 24. Product Number (CFN): 8888212416; UDI-DI: 10884521788480; Lot numbers: 243160028, 250760159, 251250036, 251320325; 25. Product Number (CFN): 8888212420; UDI-DI: 10884521788497; Lot numbers: 241350005, 250310006, 251740192, 252160037; 26. Product Number (CFN): 8888211424; UDI-DI: 10884521788459; Lot numbers: 250830185, 250830186, 250900298, 250900299, 251740179, 251950033;
Where was it sold?
US Nationwide distribution.
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.
More recalls from Mozarc Medical US
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recalled | Mozarc Medical US | Packaging Defects | Nationwide |
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