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U.S. Department of Health and Human Services

Class 2 Device Recall coaxial interventional needle (BIM)

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  Class 2 Device Recall coaxial interventional needle (BIM) see related information
Date Initiated by Firm April 21, 2021
Create Date July 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-2164-2021
Recall Event ID 88213
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
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
Code Information Affected Lot Numbers:  BIM 18/10: LOT: 4918;  BIM 18/15: LOT: 4017, 4918, 4719;  BIM 18/20: LOT: 4017, 4918;  BIM 16/10: LOT: 4918, 1119, 1219;  BIM 16/15: LOT: 4918, 1119;  BIM 16/20: LOT: 4918, 1119;  BIM 14/10: LOT: 4918, 3019;  BIM 14/15: LOT: 4918;  BIM 14/20: LOT: 4918
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 2		 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.
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