Device recall: Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM…
Class II FDA enforcement event 88213. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
INNOVATIVE TOMOGRAPHY PRODUCT GMBH started this device recall on 21 Apr 2021. The firm address in the FDA record is in Bochum. FDA put the recall in Class II. FDA event 88213 has 3 product records. The first FDA enforcement report date is 4 Aug 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the state of CA.
Recalling firm
INNOVATIVE TOMOGRAPHY PRODUCT GMBH, Bochum, N/A, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2162-2021 | 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… | N/A | Class II | Ongoing | 4 Aug 2021 |
| Z-2163-2021 | 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… | N/A | Class II | Ongoing | 4 Aug 2021 |
| Z-2164-2021 | 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,… | N/A | Class II | Ongoing | 4 Aug 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 3
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-2162-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 88213. https://recallregister.com/fda/ii/88213/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the state of CA.
- What quantity of product is in FDA event 88213?
- The event has 3 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.