FDA Medical Device Recalls (openFDA)
Resource Optimization & Innovation Llc: Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
- Recall number
- Z-1580-2017
- Recalling firm
- Resource Optimization & Innovation Llc
- Product
- Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
- Status
- Terminated
- Initiated
- 2017-01-09
- Posted
- not on file
- Terminated
- 2018-09-28
- Reason
- Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
- Root cause
- Nonconforming Material/Component
- Action
- ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.
- Quantity
- 117 kits
- Distribution
- US Distribution to LA and TX.
- Lot, serial or model codes
- 028316C Exp Date 2017-03-30; 028909C Exp Date 2017-03-30
- 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