Mozarc Medical US LLC recalls Mahurkar Elite PASS Trays
Reason for recall
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- UDI
- 10884521788541
- Lot #
- 241620022, 252020038; 2. Product Number (CFN): 8888222416
- UDI
- 10884521788602
- Lot #
- 241690023, 241830147; 3. Product Number (CFN): 8888221416
- UDI
- 10884521788558
- Lot #
- 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420
- UDI
- 10884521788619
- Lot #
- 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420
- UDI
- 10884521788565
- Lot #
- 241620407, 251950032; 6. Product Number (CFN): 8888222424
- UDI
- 10884521788626
- Lot #
- 243040007; 7. Product Number (CFN): 8888221424
- UDI
- 10884521788572
- Lot #
- 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430
- UDI
- 10884521788589
- Lot #
- 251250042; 9. Product Number (CFN): 8888233413
- UDI
- 10884521788718
- Lot #
- 250310009; 10. Product Number (CFN): 8888233416
- UDI
- 10884521788725
- Lot #
- 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420
- UDI
- 10884521788732
- Lot #
- 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420
- UDI
- 10884521788688
- Lot #
- 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424
- UDI
- 10884521788749
- Lot #
- 251740197, 252300054; 14. Product Number (CFN): 8888231424
- UDI
- 10884521788695
- Lot #
- 251460351, 251740196, 252020045, 252230022, 252580024; 15. Product Number (CFN): 8888231430
- UDI
- 10884521788701
- Lot #
- 252730009; 16. Product Number (CFN): 8888231413
- UDI
- 10884521788664
- Lot #
- 250310010; 17. Product Number (CFN): 8888231416
- UDI
- 10884521788671
- Lot #
- 252230021, 252510030, 252650294, 253140280; 18. Product Number (CFN): 8888213416
- UDI
- 10884521788527
- Lot #
- 252300325; 19. Product Number (CFN): 8888211416
- UDI
- 10884521788435
- Lot #
- 241060237, 250830187, 250900067, 251250037, 251430012, 252870014; 20. Product Number (CFN): 8888213420
- UDI
- 10884521788534
- Lot #
- 252300051; 21. Product Number (CFN): 8888211420
- UDI
- 10884521788442
- Lot #
- 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034; 22. Product Number (CFN): 8888212413
- UDI
- 10884521788473
- Lot #
- 242950260; 23. Product Number (CFN): 8888211413
- UDI
- 10884521788428
- Lot #
- 252510028; 24. Product Number (CFN): 8888212416
- UDI
- 10884521788480
- Lot #
- 243160028, 250760159, 251250036, 251320325; 25. Product Number (CFN): 8888212420
- UDI
- 10884521788497
- Lot #
- 241350005, 250310006, 251740192, 252160037; 26. Product Number (CFN): 8888211424
- UDI
- 10884521788459
- Lot #
- 250830185, 250830186, 250900298, 250900299, 251740179, 251950033
Show 42 more code fieldsShow fewer
What the firm is doing
On April 29, 2026 URGENT: MEDICAL DEVICE FIELD NOTICE letters were sent to customers. Actions to be taken: 1. If the Clinician notes that the Tegaderm dressing is not in the tray before or during Mahurkar" Elite PASS Tray use, an alternate sterile catheter dressing may be used as is customary in hospital settings where sterile dressings are routinely available as the standard clinical practice for dialysis catheters. 2. Share this notice with those who need to be aware within your organization or to any organization including, but not limited to, surgeons, interventionalists, or other staff. 3. Please maintain a copy of this notice in your records.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2319-2026
- FDA 510(k) clearance · K120674The device's official FDA premarket clearance record
- FDA device classification · MPBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5540The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Mozarc Medical US LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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