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Field reports on stuff that let you down

FDA device recallMedications· Howmedica Osteonics Corp.

TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.

Official notice from a government agency or its published feed.

TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Reason: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.

Hazard: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small …

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