Resource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects
Resource Optimization & Innovation LLC is recalling Regard SRHS Central Line Kits because holes in the packaging may compromise the sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard involves a potential compromise of the sterile field due to packaging defects, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 12,640 units of Regard SRHS Central Line Kits, sterile, 20/case. The product is intended for the flushing of indwelling vascular access devices.
The recall was initiated because the product may exhibit holes in the packaging. This defect impacts package integrity and potentially compromises the sterile field. The affected item number is 303399REG, with specific lot numbers including 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270569.
The product was distributed nationwide in the United States, including in the states of Missouri and North Carolina. Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
- Manufacturer
- Resource Optimization & Innovation LLC
- Category
- Medical Device — Vascular Access
- Affected units
- 12,640
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 (13)
- Item number 303399REG: lot numbers: 257967
- 259035
- 260742
- 259418
- 261252
- 261888
- 263836
- 264669
- 268918
- 271005
- 265730
- 270198
- and 270567.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Resource Optimization & Innovation LLC 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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