Gynecological Robotic Pack Recalled for Visualization System Discoloration
AVID Medical's GYN ROBOTIC PACK medical convenience kits have been recalled due to inadvertent resterilization causing discoloration of the visualization system. The recall affects 45 units distributed in six states.
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: This is a Class II medical device recall affecting a critical surgical visualization system component. The discoloration represents a potential risk to patient safety during gynecological robotic procedures, though no illnesses or injuries have been reported to date.
Plain-English summary
AVID Medical, Inc. is recalling its GYN ROBOTIC PACK medical convenience kit due to discoloration of the CLEARIFY VISUALIZATION SYSTEM component. The discoloration resulted from the kits being inadvertently resterilized during processing.
The recall affects 45 units distributed to healthcare facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The affected lot numbers are 1620573, 1620572, 1621883, 1621884, and 1628673. The affected units have Model Number NAMC474-01 and UDI 10809160375044.
The recalled product
- Product
- GYN ROBOTIC PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
- sterilization-error
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. NAMC474-01
- UDI: 10809160375044
- Kit Lot No. 1620573
- 1620572
- 1621883
- 1621884
- 1628673.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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