—#153000

Product

Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: 028316C Exp Date 2017-03-30; 028909C Exp Date 2017-03-30

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Resource Optimization & Innovation Llc
Address: 2909 N Neergard Ave, Springfield, Missouri 65803-6317

Distribution

Distribution pattern: US Distribution to LA and TX.

Timeline

Recall initiated: 2017-01-09
Terminated: 2018-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.