PlainRecalls
FDA Devices Moderate Class II Ongoing

Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.

Reported: November 29, 2017 Initiated: September 25, 2017 #Z-0169-2018

Product Description

Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.

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.

Details

Units Affected
51 units
Distribution
Distributed domestically to Texas.
Location
Springfield, MO

Frequently Asked Questions

What product was recalled? ▼
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.. Recalled by Resource Optimization & Innovation Llc. Units affected: 51 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0169-2018.

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