Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extens
FDA device recall Z-2319-2026 · posted 2026-06-05 · Open, Classified
Recall details
- Recalling firm
- Mozarc Medical US LLC
- Reason for recall
- The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MPB
- Quantity affected
- 25627
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-04-29
- Date posted
- 2026-06-05
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (K120674) | Covidien | 2012-04-04 |