[pending] Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Cathete
Pending LLM rewrite. Source: FDA_DEVICE Z-2319-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
The recalled product
- 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 wi
- Manufacturer
- Mozarc Medical US LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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