Cardiac Visualization System Discoloration in AVID Medical Device Kits
AVID Medical recalls HVI Cardiac Robot Pack medical kits due to inadvertent resterilization of the CLEARIFY Visualization System, causing discoloration. No injuries reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recall with no reported injuries or illnesses. The stated issue is discoloration resulting from inadvertent resterilization, without explicit identification of a safety risk in the source material.
Plain-English summary
AVID Medical, Inc. is recalling HVI Cardiac Robot Pack medical convenience kits due to inadvertent resterilization of the CLEARIFY Visualization System component, which caused discoloration in the affected units.
The recalled kits are identified by model number RYCB72-04 with Kit Lot No. 1625487. Twenty units were distributed domestically across California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- HVI CARDIAC ROBOT PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- 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. RYCB72-04
- UDI: 10809160434666
- Kit Lot No. 1625487.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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