Class 2 Device Recall coaxial interventional needle (KIR)

• Date Initiated by Firm: April 21, 2021
• Create Date: July 29, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2163-2021
• Recall Event ID: 88213
• Product Classification: Needle, aspiration and injection, disposable - Product Code GAA
• 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
• Code Information: Affected Lot Numbers: KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520; KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520; KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420; KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220; KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220 KIR 23/15: LOT: 1417, 0418, 3319, 2420; KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220; KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820; KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820; KIR 21/20: LOT: 3617, 1020; KIR17/15: LOT: 2417, 5117, 0918; KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720
• Recalling Firm/ Manufacturer: INNOVATIVE TOMOGRAPHY PRODUCT GMBH; Universitatsstr. 136; Bochum Germany
• Manufacturer Reason for Recall: Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
• FDA Determined Cause: Vendor change control
• Action: On April 20, 2021, Innovative Tomography Products GmbH issued a "urgent Safety Information Product Recall" notification to affected consignees via E-Mail. In addition to informing consignees about the recall products, the firm asked consignees mo to take the following actions: 1. We request that you immediately check your stock of the products in question with the LOT numbers indicated. Please block the corresponding products and quarantine them. 2. Please complete the attached response letter and return it to ITP via E-Mail to the following address: Address: ITP GmbH R¿ckrufunterlagen Universit¿tsstra¿e 136 44799 Bochum Germany Contact person: Dominik Fr¿mke Tel.: +49 234 54621942 Fax: +49 234 54622444 E-Mail: fraemke@innotom.com 3. Upon receipt of the documents, we will contact you to retrieve and exchange the products. Information sharing: 4. Please inform all persons within your company belonging to the circle of users about this urgent safety
• Distribution: US Nationwide distribution in the state of CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.