General laparoscopy packs contain an inadvertently resterilized visualization system
Gen Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 321 units are affected.
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 recall over discoloration from an unintended resterilization, with no device defect or clinical consequence stated in the source.
Plain-English summary
The Gen Laparoscopy Pack medical convenience kit, model number VMCC007-12, UDI 10809160357200, is being recalled. The action covers 321 units across kit lots including 1592617, 1598707, 1608042 and 1608043.
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 numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- GEN LAPAROSCOPY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 321
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 (7)
- Model No. VMCC007-12
- UDI: 10809160357200
- Kit Lot No. 1592617
- 1598707
- 1608042
- 1608043
- 1621654.
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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