FDAApril 21, 2021device
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
What to do
FDA enforcement status: Ongoing
Brands named
innovative tomography productinnovativeinnovative tomography
Recall history
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