Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Reported: November 4, 2015 Initiated: August 25, 2015 #Z-0184-2016
Product Description
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
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.
Details
- Recalling Firm
- Resource Optimization & Innovation Llc
- Units Affected
- 84 kits
- Distribution
- Distributed in Texas and Louisiana.
- Location
- Springfield, MO
Frequently Asked Questions
What product was recalled? ▼
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.. Recalled by Resource Optimization & Innovation Llc. Units affected: 84 kits.
Why was this product recalled? ▼
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0184-2016.
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