—#139676

Product

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 25787E, exp. date 1/19/2017

Why it was recalled

The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

Root cause (FDA determination)

Component design/selection

Action the firm took

ROi sent a Notice of Correction/Removal letter dated August 25, 2015, to all affected customers. The letter notified customers that ROi recently received notice of a voluntary recall from Edwards Lifesciences regarding their Transducer Kit. ROi also sent an email to their customer on September 25, 2015, informing them of the recall. Attached to the email was the component manufacturer's recall notice and a recall notice from the recalling firm. The recalling firm's recall notice instructed their customer to respond to the notice indicating whether they had any of the recalled product remaining and to destroy any remaining product in their inventory. For questions regarding this recall call 417-820-2793.

Recalling firm

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

Distribution

Distribution pattern: Product was distributed to one customer in Oklahoma.

Timeline

Recall initiated: 2015-08-25
Posted by FDA: 2015-11-05
Terminated: 2017-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139676. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.