Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
FDA device recall Z-0185-2016 · posted 2015-10-30 · Terminated
Recall details
- Recalling firm
- Resource Optimization & Innovation Llc
- Reason for recall
- Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Action taken
- 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 notice.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LHC
- Quantity affected
- 80 kits
- Distribution
- Distributed in Texas and Louisiana.
- Date initiated
- 2015-08-25
- Date posted
- 2015-10-30
- Date terminated
- 2017-04-06
- Location
- Springfield, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED (K142080) | Ecolab, Inc. | 2014-08-28 |