Mahurkar Elite PASS trays shipped without the labeled Tegaderm CHG dressing
Mahurkar Elite PASS Trays are being recalled because the Tegaderm CHG dressing specified in the product labeling was missing from certain lots. 25,627 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where a labeled component is missing from the kit, with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
Mahurkar Elite PASS Trays from Mozarc Medical US LLC are being recalled, covering acute dual lumen catheter trays including the 12 FR x 13 cm straight extension tray (CFN 8888221413), the 12 FR x 16 cm curved extension tray (8888222416) and the 12 FR x 16 cm straight extension tray (8888221416), among others listed in the recall notice. The action covers 25,627 units.
The stated reason is that the Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was nationwide in the United States. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by Mozarc Medical.
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 — Catheter tray
- Affected units
- 25,627
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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