Regard recall: Sterility Concern
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
Why was Regard recalled?
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
19345
- Product
- Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 28 kits
- Distribution
- Distributed in Texas and Louisiana.
- Recall date
- November 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)