FDA Medical Device Recalls (openFDA)
INNOVATIVE TOMOGRAPHY PRODUCT GMBH: 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)
- Recall number
- Z-2162-2021
- Recalling firm
- INNOVATIVE TOMOGRAPHY PRODUCT GMBH
- Product
- 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)
- Status
- Open, Classified
- Initiated
- 2021-04-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
- Root 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 Rckrufunterlagen Universittsstrae 136 44799 Bochum Germany Contact person: Dominik Frmke 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
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the state of CA.
- Lot, serial or model codes
- Affected Lot Numbers: KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820; KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820; KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520; KIM 22/15: LOT: 1417, 2118,4319; KIM 20/10: LOT: 4318; KIM 20/15: LOT: 4318; KIM 18/10: LOT: 0717, 4318; KIM 18/10T: LOT: 0217; KIM 18/15: LOT: 0717, 4318, 0920; KIM 18/15T: LOT: 4318; KIM 18/20: LOT: 4318; KIM 13/04T: LOT: 0817, 4318; KIM 13/09T: LOT: 0817, 4318; KIM 13/14T: LOT: 0817, 4318; KIM 15/04T: LOT: 2818; KIM 15/09T: LOT: 2818; KIM 15/14T: LOT: 2818; KIM 16/04T: LOT: 2818, 4820; KIM 16/09T: LOT: 2818, 4820, 5020; KIM 16/14T: LOT: 2818, 4820; KIM 14/20T: LOT: 2419;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 3014408997
- Firm city
- Bochum
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28