Laparoscopic Prostatectomy Kits Recalled Due to Visualization System Discoloration
AVID Medical is recalling laparoscopic prostatectomy convenience kits distributed to seven states because the CLEARIFY VISUALIZATION SYSTEM component was inadvertently resterilized, causing discoloration that may affect surgical visualization.
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 FDA recall of surgical equipment with no reported illnesses or injuries. The visualization system discoloration represents a potential risk to patient safety during laparoscopic surgery, meeting the criteria for High severity as a risk-of-harm product without reported harm.
Plain-English summary
AVID Medical, Inc. is recalling laparoscopic prostatectomy medical convenience kits distributed to surgical facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The recalled kits contain Model No. NIHB0036-07 with Kit Lot Numbers 1589877 and 1612565.
The CLEARIFY VISUALIZATION SYSTEM component within these kits was inadvertently resterilized during processing, resulting in discoloration of the visualization system. This discoloration may impact the clarity and functionality of the visualization system during laparoscopic surgical procedures.
Healthcare facilities that received affected kits should stop using them and contact AVID Medical, Inc. immediately for replacement or further guidance. Patients and providers with questions about potentially affected equipment should contact the manufacturer.
The recalled product
- Product
- LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- visualization-defect
- device-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 (4)
- Model No. NIHB0036-07
- UDI: 10809160403099
- Kit Lot No. 1589877
- 1612565.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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