FDA Medical Device Recalls (openFDA)
Resource Optimization & Innovation Llc: 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.
- Recall number
- Z-0229-2016
- 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.
- Status
- Terminated
- Initiated
- 2015-08-25
- Posted
- 2015-11-05
- Terminated
- 2017-04-06
- Reason
- 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
- 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
- 255 packs
- Distribution
- Product was distributed to one customer in Oklahoma.
- Lot, serial or model codes
- Lot 25787E, exp. date 1/19/2017
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3004513970
- Firm city
- Springfield
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28