FDA Medical Device Recalls (openFDA)
Resource Optimization & Innovation Llc: Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
- Recall number
- Z-2798-2015
- Recalling firm
- Resource Optimization & Innovation Llc
- Product
- Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
- Status
- Terminated
- Initiated
- 2015-08-19
- Posted
- 2015-09-21
- Terminated
- 2017-04-05
- Reason
- Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
- 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
- 24 kits
- Distribution
- Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
- Lot, serial or model codes
- 023735
- 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