AVID Medical Thoracoscopy Basin Kits Recalled for Discoloration
AVID Medical is recalling 128 Major Thoracoscopy Basin medical convenience kits due to discoloration caused by inadvertent resterilization during manufacturing.
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 an FDA Class II recall involving a manufacturing defect that caused discoloration of a surgical visualization component. While no injuries or illnesses have been reported, the defect presents a potential risk of harm during thoracoscopic procedures where visualization is critical.
Plain-English summary
AVID Medical, Inc. is recalling 128 Major Thoracoscopy Basin medical convenience kits that include the Clearify Visualization System component. During manufacturing, the kits were inadvertently resterilized, causing discoloration of the visualization system.
The affected kits were distributed to medical facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
Healthcare providers and facilities that received affected kits should contact AVID Medical, Inc. immediately for instructions on handling the recalled units.
The recalled product
- Product
- MAJOR THORACOSCOPY BASIN. 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 (14)
- Model No. NIHB0022-09
- NIHB0022-11
- NIHB0022-12
- UDI: 10809160381311
- 10809160403730
- 10809160440940
- Kit Lot No. 1580032
- 1590461
- 1590463
- 1604743
- 1613180
- 1613182
- 1618989
- 1641040.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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