Regard Custom Surgical Pack Recalled for Chemical Contamination and Sterility Issues
Resource Optimization & Innovation Llc is recalling 67 Regard Custom Surgical Packs due to potential chemical contamination and lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance and chemical contamination in a product used for invasive cardiovascular surgery, which poses a significant risk of serious injury or infection.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 67 units of the Regard Custom Surgical Pack, Item Number 800208002. These sterile kits, identified by code 025072B, are used in cardiovascular surgical procedures, specifically for CABG A&B.
The recall was initiated because the surgical kits contain a surgical scrub product that may be chemically contaminated and lacks sterility assurance. The affected products were distributed to one customer in Lake Charles, Louisiana, and one customer in Spartanburg, South Carolina.
Hospitals and healthcare facilities that received these products should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 67
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 (1)
- 025072B
Distribution
Distribution scope not specified by the agency.
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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