Recalls / —

—#153096

Product

Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

027750A Exp Date 2017-08-24; 028676A Exp Date 2017-10-13; 029916A Exp Date 2017-12-08; 030661A Exp Date 2018-01-04; 034835A Exp Date 2018-07-11;

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 #153096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.