FDA-Device2024-11-20Class II
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
Hazard
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Sold states
US Nationwide distribution.
Affected count
42 eaches
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0391-2025More AVID Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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