Laparoscopic GYN kits contain an inadvertently resterilized visualization system
Laparoscopic GYN medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 18 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 Laparoscopic GYN medical convenience kit, model number EURO011-08, UDI 10809160414248, is being recalled. The action covers 18 units from kit lot 1613056.
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
- LAPAROSCOPIC GYN. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 18
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. EURO011-08
- UDI: 10809160414248
- Kit Lot No. 1613056.
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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