Recall Z-0229-2016 ยท LRO General Surgery Tray
Resource Optimization & Innovation Llc
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.
| Date | Nov 5, 2015 (initiated Aug 25, 2015) |
| Status | Terminated |
| Reason | 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 | Component design/selection |
| Action | 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 remaini |
| Quantity | 255 packs |
| Distribution | Product was distributed to one customer in Oklahoma. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.