Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Resource Optimization & Innovation Llc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Product Codes/Lot Numbers:
Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0169-2018
Related Recalls
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Resource Optimization & Innovation
A kit component, the PDI Prevantics Swab, was recalled.
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
Resource Optimization & Innovation
The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Resource Optimization & Innovation
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.