Recall Z-2319-2026
- Recall number
- Z-2319-2026
- Event number
- 98891
- Firm
- Mozarc Medical US LLC
- Firm FEI
- 3030574705
- Product code
- MPB
- Status
- Open, Classified
- Initiated
- 2026-04-29
- Posted
- 2026-06-05
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K120674, K192302, K980438, K991431, K163458, K192807, K993933, K923691, K110793, K071145, K984022, K880583, K991320, K122091, K896252, K102833, K955002, K063355, K100451, K963446, K200426, K001958, K974236, K030268, K070234, K040301, K161504, K010778, K022221, K952660
Product#
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.
Reason for Recall#
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.