Robotic Surgical Kit Recalled for Visualization System Discoloration
AVID Medical is recalling 372 Robotic Uro/Gyn Packs in which the visualization system was inadvertently resterilized, causing discoloration. Affected products were distributed domestically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
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 recall qualifies for Score 3 (High) per the rubric as a risk-of-harm product where injury has not yet been reported. The visualization system in this surgical kit is critical to procedural success and patient safety; discoloration could compromise optical function and visibility during procedures.
Plain-English summary
AVID Medical, Inc. is recalling 372 units of the Robotic Uro/Gyn Pack, a medical convenience kit used in urological and gynecological procedures. The visualization system components in these kits were inadvertently resterilized during manufacturing, resulting in discoloration.
The recalled units include Model No. RDLD050-09 (UDI: 10809160413715) with the following lot numbers: 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, and 1633997. The affected products were distributed domestically to healthcare providers and facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
Healthcare providers with affected kits should contact AVID Medical, Inc. for further information and guidance regarding the recalled products.
The recalled product
- Product
- ROBOTIC URO/GYN 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 (9)
- Model No. RDLD050-09
- UDI: 10809160413715
- Kit Lot No. 1604510
- 1604511
- 1604512
- 1606486
- 1629590
- 1633995
- 1633997.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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