The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2163-2021·Announced 2021-08-04

Coaxial Interventional Needles recalled for potential sterilization failure

Coaxial Interventional Needles from INNOVATIVE TOMOGRAPHY PRODUCT GMBH may not be properly sterilized. Multiple lot numbers are affected and should not be used.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for an invasive medical device with inadequate sterilization, which poses risk of infection. Per the rubric, Class II recalls for serious risk-of-harm products where injury has not been reported qualify as High (3) severity. The recall notice contains no indication of reported illnesses or adverse events.

Plain-English summary

INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling Coaxial Interventional Needles that are labeled as sterile because they may not have been adequately sterilized. This is a Class II recall by the FDA.

The recalled products include multiple article numbers: KIR 23/05, KIR 23/05N, KIR 23/07, KIR 23/07N, KIR 23/10, KIR 23/15, KIR 21/10, KIR 21/12, KIR 21/15, KIR 21/20, KIR 17/15, and KIR 17/15:45. Each article number has specific lot numbers listed as affected. The needles vary in length from 50 mm to 200 mm and in diameter from 17G to 23G.

These needles have been distributed in California. Healthcare providers and patients who have these devices should not use the affected lot numbers and should contact INNOVATIVE TOMOGRAPHY PRODUCT GMBH immediately for instructions on return or replacement. The affected devices should be removed from inventory.

The recalled product

Product
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…
Manufacturer
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Category
Medical Device — Interventional needle
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Affected Lot Numbers: KIR 23/05: LOT: 2516
  • 5016
  • 1417
  • 0718
  • 3318
  • 4318
  • 3819
  • 1520
  • KIR 23/05N: LOT: 0717
  • 5117
  • 0518
  • KIR 23/07: LOT: 2516
  • 4216
  • 3617
  • 2119
  • 3320
  • 4420
  • KIR 23/07N: LOT: 2916
  • 4516
  • 0717

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by INNOVATIVE TOMOGRAPHY PRODUCT GMBH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · INNOVATIVE TOMOGRAPHY PRODUCT GMBH

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Same hazard · sterilization failure

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