HVI cardiac robot packs contain an inadvertently resterilized visualization system
HVI Cardiac Robot Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 20 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall over discoloration from an unintended resterilization, with no device defect or clinical consequence stated in the source.
Plain-English summary
The HVI Cardiac Robot Pack medical convenience kit, model number RYCB72-04, UDI 10809160434666, is being recalled. The action covers 20 units from kit lot 1625487.
The stated reason is that the Clearify Visualization System was inadvertently resterilized in the kits, causing discoloration. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was domestic, to California, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington. The kits are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI and kit lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- HVI CARDIAC ROBOT PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 20
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
Part of a larger recall action
This product is one of 24 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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