AVID Medical General Laparoscopy Tray Recalled for Discolored Visualization System
AVID Medical is recalling 574 General Laparoscopy Trays due to inadvertent resterilization causing discoloration of the CLEARIFY VISUALIZATION SYSTEM. The discoloration could compromise surgical visibility.
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 with no reported injuries or illnesses. The discoloration of the CLEARIFY VISUALIZATION SYSTEM presents a potential risk of compromised surgical visualization during laparoscopic procedures.
Plain-English summary
AVID Medical, Inc. is recalling 574 General Laparoscopy Trays, which are medical convenience kits used in laparoscopic surgical procedures. The affected trays contain a CLEARIFY VISUALIZATION SYSTEM component.
The trays were inadvertently resterilized during preparation, causing discoloration of the CLEARIFY VISUALIZATION SYSTEM. Discoloration of the visualization system could compromise the surgeon's ability to visualize the surgical field clearly during laparoscopic procedures.
The recall affects trays distributed domestically to healthcare facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Affected units can be identified by Model Nos. EURO010-08, USAR042-17, WILF006-29. Lot numbers affected include 1616570, 1581675, 1594938, 1597550, 1600846, 1620149, 1620150, 1620151, and 1622920.
No illnesses or injuries have been reported. Healthcare facilities that received these trays should discontinue use and contact AVID Medical, Inc. for replacement or further instructions.
The recalled product
- Product
- GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
- visualization-impairment
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 (16)
- Model No. EURO010-08
- USAR042-17
- WILF006-29
- UDI: 10809160414309
- 10809160400586
- 10809160429914
- 10809160431108
- Kit Lot No. 1616570
- 1581675
- 1594938
- 1597550
- 1600846
- 1620149
- 1620150
- 1620151
- 1622920.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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