Cardiac visualization system recalled due to discoloration from inadvertent resterilization
AVID Medical is recalling the CARDIAC ROBOT PACK medical convenience kit after inadvertent resterilization caused discoloration of the visualization system. Twenty units distributed across seven U.S. states are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting a cardiac visualization system. While no injuries have been reported, the inadvertent resterilization and resulting discoloration of a visualization system in a high-risk cardiac procedure context represents a risk of harm that has not yet resulted in reported patient injury.
Plain-English summary
AVID Medical, Inc. is recalling the CARDIAC ROBOT PACK, a medical convenience kit containing the CLEARIFY VISUALIZATION SYSTEM. The affected units consist of 20 kits identified by Model No. RYCB72-03, UDI 10809160422830, and Kit Lot No. 1608339.
The recalled units were inadvertently resterilized during manufacturing, resulting in discoloration of the visualization system. FDA classified this as a Class II recall.
The affected kits were distributed to healthcare facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
Customers in possession of affected units should contact AVID Medical, Inc. for information regarding the recall and available options.
The recalled product
- Product
- CARDIAC ROBOT PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- manufacturing-defect
- discoloration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. RYCB72-03
- UDI: 10809160422830
- Kit Lot No. 1608339.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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