CLASS II ONGOING Device recall · Reported 4 Aug 2021 · FDA Enforcement Report
Coaxial Interventional Needle, ITP innotom.com, CE recalled
Innovative Tomography Product is recalling Coaxial Interventional Needle, ITP innotom.com, CE 0297, Sterile EO for the following, distributed nationwide in the US. The recall was initiated on 21 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2163-2021
- FDA event ID
- 88213
- Recalling firm
- Innovative Tomography Product, Bochum, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2021
- FDA classified
- 29 Jul 2021
- Reported
- 4 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 21 Apr 2021 | Recall initiated by company | |
| 29 Jul 2021 | Classified by FDA | +99 days |
| 4 Aug 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US
Where it was distributed
US Nationwide distribution in the state of CA.
Questions about this recall
Why was it recalled?
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Which lots are affected?
Affected Lot Numbers: KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520; KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520; KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420; KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220; KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220 KIR 23/15: LOT: 1417, 0418, 3319, 2420; KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220; KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820; KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820; KIR 21/20: LOT: 3617, 1020; KIR17/15: LOT: 2417, 5117, 0918; KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720;
Where was it sold?
US Nationwide distribution in the state of CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88213This product is part of a recall event; the main page for the event is Semi-automatic Biopsy-Needle, ITP innotom.com, CE recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Semi-automatic Biopsy-Needle, ITP innotom.com, CE recalled | Innovative Tomography Product | Sterility | Nationwide | |
| CLASS II | Coaxial Interventional Needle, ITP innotom.com, CE recalled | Innovative Tomography Product | Sterility | Nationwide |
More recalls from Innovative Tomography Product
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Coaxial Interventional Needle, ITP innotom.com, CE recalled | Innovative Tomography Product | Sterility | Nationwide |
| Device | CLASS II | Semi-automatic Biopsy-Needle, ITP innotom.com, CE recalled | Innovative Tomography Product | Sterility | Nationwide |
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| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |