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INNOVATIVE TOMOGRAPHY PRODUCT GMBH recalls Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. K
Recalled August 4, 2021 · FDA recall Z-2163-2021 · INNOVATIVE TOMOGRAPHY PRODUCT
Hazard
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized · FDA Class II
Units
N/A
Sold at
US Nationwide distribution in the state of CA.
Description
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Product
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. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US
Manufacturer(s)
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →