Resource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
Resource Optimization & Innovation LLC is recalling Regard SRHS GIC Port A Cath devices 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 3/5 (High).
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, and the hazard involves a potential compromise of the sterile field for a medical device, which presents a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 9,360 units of Regard SRHS GIC Port A Cath, sterile, quantity 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, which impacts package integrity and potentially compromises a sterile field.
The affected product is identified by item number 303394REG and includes lot numbers 259427, 262441, 264440, 268589, 268915, 271008, and 269694. The recall covers US nationwide distribution, including the states of Missouri and North Carolina.
The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare providers and consumers should check their inventory for the specific item and lot numbers listed above and stop using the affected units.
The recalled product
- Product
- Regard SRHS GIC Port A Cath, Sterile, Qty 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
- 9,360
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 (7)
- Item number 303394REG: lot numbers: 259427
- 262441
- 264440
- 268589
- 268915
- 271008
- and 269694.
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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