FDA-Device2026-09-02Class IIMISBRANDING
Halyard TOTAL JOINT medical kit recalled for undisclosed latex in component
What this means
The Halyard TOTAL JOINT medical kit (Model MSBM036-03) contains a statlock component made of natural rubber latex, but the kit's labeling does not warn of this. People with latex allergies could have a serious allergic reaction if exposed during use.
- If you have a latex allergy and have this kit, do not use it.
- Contact your healthcare provider or Halyard for a replacement kit.
- Return unused kits to your supplier or contact the manufacturer for instructions.
The agency's original wording
Hazard
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MS, TX.
Affected count
78 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3007-2026More AVID Medical recalls
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