Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coaxial Interventional Needle Recalled by INNOVATIVE TOMOGRAPHY PRODUCT GMBH Due to Sterility Assurance; Coaxial Interventional Needle labeled as sterile...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact INNOVATIVE TOMOGRAPHY PRODUCT GMBH directly.
Affected Products
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)
Quantity: N/A
Why Was This Recalled?
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About INNOVATIVE TOMOGRAPHY PRODUCT GMBH
INNOVATIVE TOMOGRAPHY PRODUCT GMBH has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report