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. 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
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