Medical Device Recall: Laparoscopy Kit Visualization System Discoloration
AVID Medical, Inc. is recalling 321 units of GEN LAPAROSCOPY PACK kits distributed in six states due to discoloration of the visualization system caused by inadvertent resterilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a surgical device component with a manufacturing defect (discoloration) affecting its primary function. With no reported injuries, this meets the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling 321 units of the GEN LAPAROSCOPY PACK (Model VMCC007-12) medical convenience kit. The kit contains a CLEARIFY VISUALIZATION SYSTEM component that was inadvertently resterilized during manufacturing, causing discoloration. Affected kit lot numbers are 1592617, 1598707, 1608042, 1608043, and 1621654.
The affected kits were distributed domestically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The FDA has classified this as a Class II recall.
The recalled product
- Product
- GEN LAPAROSCOPY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- 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 (7)
- Model No. VMCC007-12
- UDI: 10809160357200
- Kit Lot No. 1592617
- 1598707
- 1608042
- 1608043
- 1621654.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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