Z-2798-2015Class II

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical...

Name: Z-2798-2015 Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical...
Creator: Resource Optimization & Innovation Llc
Published: 2015-08-19
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2015-08-19 / Terminated / root cause: manufacturing process

FDA source

Resource Optimization & Innovation Llc began a recall of Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures on 2015-08-19. FDA classified it as Class II and gives the reason as "Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2798-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-19
Posted: 2015-09-21
Terminated: 2017-04-05
Recalling firm: Resource Optimization & Innovation, LLC
Product: Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
Product code: LRO General Surgery Tray
Reason for recall: Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.
Quantity in commerce: 24 kits
Distribution: Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
Product codes and lots: 023735

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2798-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2798-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21
Z-2799-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)