Class II Recall

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Exte

Summary

The FDA issued a Class II for Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acut by Mozarc Medical US LLC. Reason: The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays..

Details

Source

Device Recall

External ID

Z-2319-2026

Action Date

2026-06-17

Status

Ongoing

Product Description

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 Info: 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;

Quantity Affected: 25627

Reason for Recall

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-04-29

Company

Mozarc Medical US LLC

Mansfield, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Mozarc Medical US LLC has 12 FDA actions in our database, including 12 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mozarc Medical US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Mozarc Medical US LLC have FDA actions?

Mozarc Medical US LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2319-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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