Reported Aug 4, 2021 · Ongoing
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers
Innovative Tomography Product GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INNOVATIVE TOMOGRAPHY PRODUCT GMBH · Universitatsstr. 136 · Bochum, N/A · N/A
Is this the product you have?
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers
8 of 8 products
| Model / number | Product as published |
|---|---|
23 | 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 |
21 | 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 |
17 | G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520 2 KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520 3 KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420 4 KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220 5 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 6 KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220 7 KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820 8 KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820 9 KIR 21/20: LOT: 3617, 1020 10 KIR17/15: LOT: 2417, 5117, 0918 11 KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720 - Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- CA
Why it was recalled
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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