FDA-Device2025-05-21Class II
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
AVID Medical, Inc.
Hazard
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Sold states
US Nationwide distribution in the states of IL & LA.
Affected count
60 units
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Products
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2025Don't want to check this manually?
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