Recall Z-0229-2016
Resource Optimization & Innovation Llc · initiated August 25, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 25787E, exp. date 1/19/2017
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.
FDA-determined cause: Component design/selection
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.
Details
- Recall number
- Z-0229-2016
- Initiated
- August 25, 2015
- Posted by FDA
- November 5, 2015
- Terminated
- April 6, 2017
- Product code
- LRO – General Surgery Tray
- Quantity
- 255 packs
- Distribution
- Product was distributed to one customer in Oklahoma.
- Recalling firm
- Resource Optimization & Innovation Llc, Springfield, MO