Reprocessed ViewFlex ICE catheters recalled over residual material particles
Medline is recalling 650 units because these lots of reprocessed catheters may contain small particles of residual material.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters, 9F x 90cm, catalog number D087031RH are being recalled by Medline Industries, LP.
The record states these lots of reprocessed catheters may contain small particles of residual material. It states that if affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. The record notes this is an expansion of recall Z-2610/2614-2025.
The record lists 650 units, with UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock and follow Medline's instructions.
The recalled product
- Product
- Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
- Manufacturer
- Medline Industries, LP
- Affected units
- 650
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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