Recall Z-0185-2016 ยท LHC Warmer, Irrigation Solution
Resource Optimization & Innovation Llc
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
| Date | Oct 30, 2015 (initiated Aug 25, 2015) |
| Status | Terminated |
| Reason | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| Root cause | Packaging |
| Action | On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the |
| Quantity | 80 kits |
| Distribution | Distributed in Texas and Louisiana. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED Ecolab, Inc., Aug 28, 2014 |