Z-2164-2021Class II

Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article...

Name: Z-2164-2021 Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article...
Creator: Innovative Tomography Product Gmbh
Published: 2021-04-21
License: https://open.fda.gov/license/

Innovative Tomography Products GmbH / initiated 2021-04-21 / Open, Classified / root cause: supplier

FDA source

INNOVATIVE TOMOGRAPHY PRODUCT GMBH began a recall of 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... on 2021-04-21. FDA classified it as Class II and gives the reason as "Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2164-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-21
Posted: 2021-07-29
Recalling firm: Innovative Tomography Products GmbH
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
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Root cause tag: supplier
FDA 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: [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2164-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-29
Z-2163-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-29
Z-2164-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-29

Product code GAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)