Urology/prostate surgical kit recalled for inadvertent resterilization causing discoloration
AVID Medical is recalling its DA VINCI PACK URO/PROSTATE surgical kits because the visualization system was inadvertently resterilized, causing discoloration.
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 medical device recall for a surgical kit with sterilization defect (inadvertent resterilization causing discoloration). Meets criteria for High severity as a risk-of-harm product used in clinical procedures, with no documented hospitalization reports that would elevate to Severe.
Plain-English summary
AVID Medical, Inc. is recalling the DA VINCI PACK URO/PROSTATE medical convenience kit. The visualization system was inadvertently resterilized, resulting in discoloration of the equipment. The affected kits have model number VAHT009-19 and kit lot number 1579555.
The recall impacts 21 units distributed in the United States, specifically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
Consumers and healthcare facilities currently using affected kits should contact AVID Medical, Inc. for instructions regarding replacement or proper disposal.
The recalled product
- Product
- DA VINCI PACK URO/PROSTATE. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
- sterilization-defect
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. VAHT009-19
- UDI: 10809160378748
- Kit Lot No. 1579555.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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