Medical visualization system kits recalled for discoloration defect
AVID Medical is recalling 626 DAVINCI TRUCUSTOM BUNDLE medical kits because the CLEARIFY VISUALIZATION SYSTEM was inadvertently re-sterilized, causing discoloration. Affected units were distributed in CA, IL, MD, OH, PA, TX, and WA.
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 medical device recall with no reported injuries or illnesses. The inadvertent re-sterilization causing discoloration represents a manufacturing quality defect warranting recall.
Plain-English summary
AVID Medical is recalling 626 units of the DAVINCI TRUCUSTOM BUNDLE medical convenience kit due to a manufacturing defect in the included CLEARIFY VISUALIZATION SYSTEM. The visualization system was inadvertently re-sterilized during production, resulting in discoloration.
The affected kits bear model numbers MAMC228-13, MAMC228-14, and MAMC228-15, and were distributed domestically to California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Consumers who have received these kits should contact AVID Medical, Inc. for instructions on how to proceed.
The recalled product
- Product
- DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
- sterilization-defect
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 (20)
- Model No. MAMC228-13
- MAMC228-14
- MAMC228-15
- UDI: 10809160366943
- 10809160366820
- 10809160420980
- 10809160421734
- 10809160441046
- Kit Lot No. 1576797
- 1577255
- 1586536
- 1606044
- 1607044
- 1607825
- 1615452
- 1621487
- 1621488
- 1638247
- 1639254
- 1647833.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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