Robotic Prostatectomy Pack Recalled Due to Discoloration from Resterilization
AVID Medical is recalling ROBOTIC PROSTATECTOMY PACK units due to inadvertent resterilization of the CLEARIFY VISUALIZATION SYSTEM, which caused discoloration. The kits were distributed domestically.
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: This is a Class II FDA medical device recall without reported illnesses or injuries. The discoloration from inadvertent resterilization is a process defect, but the source text does not indicate serious risk of harm or functional impairment.
Plain-English summary
AVID Medical, Inc. is recalling ROBOTIC PROSTATECTOMY PACK, a medical convenience kit used in robotic prostatectomy procedures. The CLEARIFY VISUALIZATION SYSTEM within these kits was inadvertently resterilized, resulting in discoloration of the equipment.
This recall was issued as a Class II medical device recall by the U.S. Food and Drug Administration.
Affected kits include Model No. NAMC423-08 with lot numbers 1624611, 1624612, and 1628010. The kits were distributed domestically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
Healthcare providers and facilities that have received these kits should review their inventory and contact AVID Medical for instructions regarding this recall.
The recalled product
- Product
- ROBOTIC PROSTATECTOMY PACK. 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 (5)
- Model No. NAMC423-08
- UDI: 10809160374627
- Kit Lot No. 1624611
- 1624612
- 1628010.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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