FDA-Device2026-09-02Class IIMISBRANDING
Halyard TOTAL JOINT surgical kit recalled for undisclosed latex in component
What this means
Halyard TOTAL JOINT medical kits (Model MSBM036-03, Lot 1632948) contain a statlock component made of natural rubber latex, but the kit labeling does not warn of this. People with latex allergies could have a serious allergic reaction if exposed during use.
- If you have this kit, do not use it.
- Check the lot number (1632948) on your kit.
- Contact your healthcare provider or Halyard Medical for instructions on safe disposal or replacement.
- If you have a known latex allergy and were exposed, seek immediate medical attention.
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
63 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-3006-2026More AVID Medical recalls
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