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
18 of 18 products
| # | Product as published |
|---|---|
| 1 | Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm |
| 2 | Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm) |
| 3 | Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm) |
| 4 | Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm) |
| 5 | Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm) |
| 6 | Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm) |
| 7 | Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm) |
| 8 | Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm) |
| 9 | Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm) |
| 10 | Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm) |
| 11 | Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm) |
| 12 | Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm) |
| 13 | Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm) |
| 14 | Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm) |
| 15 | Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm) |
| 16 | Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm) |
| 17 | Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm) |
| 18 | Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm) |
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820 2 KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820 3 KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520 4 KIM 22/15: LOT: 1417, 2118,4319 5 KIM 20/10: LOT: 4318 6 KIM 20/15: LOT: 4318 7 KIM 18/10: LOT: 0717, 4318 8 KIM 18/10T: LOT: 0217 9 KIM 18/15: LOT: 0717, 4318, 0920 10 KIM 18/15T: LOT: 4318 11 KIM 18/20: LOT: 4318 12 KIM 13/04T: LOT: 0817, 4318 13 KIM 13/09T: LOT: 0817, 4318 14 KIM 13/14T: LOT: 0817, 4318 15 KIM 15/04T: LOT: 2818 16 KIM 15/09T: LOT: 2818 17 KIM 15/14T: LOT: 2818 18 KIM 16/04T: LOT: 2818, 4820 19 KIM 16/09T: LOT: 2818, 4820, 5020 20 KIM 16/14T: LOT: 2818, 4820 - 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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