Z-0169-2018Class II

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

Name: Z-0169-2018 Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a...
Creator: Resource Optimization & Innovation Llc
Published: 2017-09-25
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2017-09-25 / Open, Classified / root cause: labeling and UDI

FDA source

Resource Optimization & Innovation Llc began a recall of Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure on 2017-09-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0169-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-09-25
Posted: 2017-11-21
Recalling firm: Resource Optimization & Innovation, LLC
Product: Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Product code: LRO General Surgery Tray
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Customer was notified of the recall via email on September 25, 2017. Instructions included identify and quarantine any affected products, notify ROi by completing and returning the completed notification form, coordinating the issuance of supplemental labeling which will instruct the end user to remove and discard the recalled ChloraPrep at the time of use. For further questions, please call (417) 820-2793
Quantity in commerce: 51 units
Distribution: Distributed domestically to Texas.
Product codes and lots: Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0169-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0169-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-29	2017-11-21

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)