Recall Z-2163-2021 ยท GAA Needle, Aspiration And Injection, Disposable
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
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 2
| Date | Apr 21, 2021 |
| Status | Open, Classified |
| 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 Univ |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.