Regard Custom Surgical Pack recall: Sterility Concern
Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
Why was Regard Custom Surgical Pack recalled?
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack 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?
023735
- Product
- Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 24 kits
- Distribution
- Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
- Recall date
- September 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)