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INNOVATIVE TOMOGRAPHY PRODUCT GMBH recalls Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BI
Recalled August 4, 2021 · FDA recall Z-2164-2021 · 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
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *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 →