FDA Recalls Regard Custom Surgical Packs Due to Flow Restriction Issues
Resource Optimization & Innovation LLC is recalling 255 Regard Custom Surgical Packs due to flow restriction issues in the trifurcated IV set.
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 involves a medical device defect (flow restriction) that poses a risk of harm during surgical procedures, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 255 units of the Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures.
The recall was initiated because the kits contain pressure monitoring kits or sets with flow restriction issues in the trifurcated IV set. The affected products are identified by Lot 25787E and have an expiration date of 1/19/2017.
The product was distributed to one customer in Oklahoma. The source text does not specify further instructions for consumers or healthcare providers regarding the handling of these recalled items.
The recalled product
- Product
- Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
- Manufacturer
- Resource Optimization & Innovation Llc
- Hazard
- Affected units
- 255
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 (2)
- Lot 25787E
- exp. date 1/19/2017
Distribution
Distributed in 1 state:
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