Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments an

FDA device recall Z-0229-2016 · posted 2015-11-05 · Terminated

Recall details

Recalling firm

Resource Optimization & Innovation Llc

Reason for recall

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

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

LRO

Quantity affected

255 packs

Distribution

Product was distributed to one customer in Oklahoma.

Date initiated

2015-08-25

Date posted

2015-11-05

Date terminated

2017-04-06

Location

Springfield, MO