ROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes
ROi CPS LLC is recalling 40 custom procedure kits because they contain PosiFlush Syringes from a lot previously recalled by BD.
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: The recall is classified as FDA Class II. The source text does not report any illnesses or injuries, and the hazard is linked to a component previously recalled by another manufacturer, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
ROi CPS LLC is voluntarily recalling 40 kits of custom procedure kits. The kits contain PosiFlush Syringes that are part of a lot previously recalled by BD.
The affected product is identified as Regard, Item number 830034, GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. The specific lot number is 68336DRW. The UDI is (01) 10326053106634 (17) 210131 (10) 68336DRW.
These kits were distributed nationwide in the United States, specifically in the states of Missouri, Arkansas, and Oklahoma. The recall is classified as Class II by the FDA. Consumers and healthcare facilities should check their inventory for this specific lot number and stop using the affected kits.
The recalled product
- Product
- Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
- Manufacturer
- ROi CPS LLC
- Affected units
- 40
Distribution
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