Z-0229-2016Class II

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical...

Name: Z-0229-2016 Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical...
Creator: Resource Optimization & Innovation Llc
Published: 2015-08-25
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2015-08-25 / Terminated / root cause: design

FDA source

Resource Optimization & Innovation Llc began a recall of Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a... on 2015-08-25. FDA classified it as Class II and gives the reason as "The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0229-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-25
Posted: 2015-11-05
Terminated: 2017-04-06
Recalling firm: Resource Optimization & Innovation, LLC
Product: Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Product code: LRO General Surgery Tray
Reason for recall: The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Root cause tag: design
FDA root cause: Component design/selection
Action: ROi sent a Notice of Correction/Removal letter dated August 25, 2015, to all affected customers. The letter notified customers that ROi recently received notice of a voluntary recall from Edwards Lifesciences regarding their Transducer Kit. ROi also sent an email to their customer on September 25, 2015, informing them of the recall. Attached to the email was the component manufacturer's recall notice and a recall notice from the recalling firm. The recalling firm's recall notice instructed their customer to respond to the notice indicating whether they had any of the recalled product remaining and to destroy any remaining product in their inventory. For questions regarding this recall call 417-820-2793.
Quantity in commerce: 255 packs
Distribution: Product was distributed to one customer in Oklahoma.
Product codes and lots: Lot 25787E, exp. date 1/19/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0229-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0229-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

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)