FDA Medical Device Recalls (openFDA)
Resource Optimization & Innovation Llc: Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
- Recall number
- Z-0189-2016
- Recalling firm
- Resource Optimization & Innovation Llc
- Product
- Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
- Status
- Terminated
- Initiated
- 2015-08-25
- Posted
- 2015-10-30
- Terminated
- 2017-04-06
- Reason
- Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Root cause
- Packaging
- Action
- On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.
- Quantity
- 17 kits
- Distribution
- Distributed in Texas and Louisiana.
- Lot, serial or model codes
- 26550
- 510(k) numbers
- ["K142080"]
- PMA numbers
- not on file
- Product code
- LHC
- 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