FDA-Device2025-09-17Class II
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Hazard
Potential for open header bag seals, compromising sterility.
Sold states
US Nationwide distribution in the state of Florida.
Affected count
228 units
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2025More 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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