Regard Custom Surgical Pack Packs contain surgical recall: Labeling Error
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Why was Regard Custom Surgical Pack Packs contain surgical recalled?
Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
- Product
- Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
- Recalling firm
- Resource Optimization & Innovation Llc
- Quantity
- 51 units
- Distribution
- Distributed domestically to Texas.
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)