Surgical Kit with Discolored Visualization System Recalled by AVID Medical
AVID Medical recalled the LAP CHOLE PACK surgical kit after the CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized, causing discoloration of the device.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Class II device with a cosmetic defect (discoloration) resulting from manufacturing error. No injuries or illnesses have been reported, and the hazard is limited to the appearance of the component.
Plain-English summary
AVID Medical, Inc. is recalling the LAP CHOLE PACK medical convenience kit due to a manufacturing defect affecting the CLEARIFY VISUALIZATION SYSTEM component. The device was inadvertently resterilized during the manufacturing process, resulting in discoloration.
The recall affects 85 units of the LAP CHOLE PACK distributed across California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Affected kits can be identified by model number VCIH007-06 and the following lot numbers: 1569227, 1569228, 1569229, 1589126, 1608615, 1623944, and 1643426.
Healthcare facilities and practitioners who have received affected kits should cease use and contact AVID Medical, Inc. for instructions on inspection, return, or replacement of the affected kits.
The recalled product
- Product
- LAP CHOLE PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kit
- 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 (10)
- Model No. VCIH007-06
- UDI: 10809160379479
- 10809160450758
- Kit Lot No. 1569227
- 1569228
- 1569229
- 1589126
- 1608615
- 1623944
- 1643426.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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