LAVH Pack Surgical Kit Recalled for Visualization System Discoloration
AVID Medical is recalling 292 LAVH Pack surgical kits due to inadvertent resterilization that caused discoloration of the CLEARIFY VISUALIZATION SYSTEM. Affected kits were distributed in seven U.S. states.
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 FDA Class II recall involves a surgical visualization component whose discoloration may impair optical function during procedures. Although no illnesses or injuries have been reported, the defect poses a potential risk of harm to patient safety through compromised intraoperative visualization, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling the LAVH Pack, a medical convenience kit used in surgical procedures. The recall affects 292 units that were distributed domestically across California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington.
The recall was initiated because the CLEARIFY VISUALIZATION SYSTEM component in the kits was inadvertently resterilized during manufacturing, causing discoloration. Discoloration of a visualization system may compromise the optical clarity needed during surgical procedures.
The affected kits are identified by Model No. USAR053-11 and carry the following lot numbers: 1578109, 1585712, 1597106, 1601742, 1601643, 1607925, 1612044, 1621429, and 1637117.
Healthcare facilities and providers in possession of affected LAVH Packs should immediately stop using them and contact AVID Medical, Inc. for guidance on return, replacement, or proper disposal.
The recalled product
- Product
- LAVH PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- visualization-impairment
- product-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 (11)
- Model No. USAR053-11
- UDI: 10809160372357
- Kit Lot No. 1578109
- 1585712
- 1597106
- 1601742
- 1601643
- 1607925
- 1612044
- 1621429
- 1637117.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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