FDAAugust 24, 2017device
IVEA Product Part Number 16100 Model 500A
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
What to do
FDA enforcement status: Terminated
Brands named
firefly medicalfirefly
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
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