Reported Aug 4, 2021 · Ongoing
Semi-automatic Biopsy-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?
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers
8 of 8 products
| Model / number | Product as published |
|---|---|
18 | 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 |
16 | G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter |
16 | G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter |
16 | G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter |
14 | G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter |
14 | G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter |
14 | G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 BIM 18/10: LOT: 4918 2 BIM 18/15: LOT: 4017, 4918, 4719 3 BIM 18/20: LOT: 4017, 4918 4 BIM 16/10: LOT: 4918, 1119, 1219 5 BIM 16/15: LOT: 4918, 1119 6 BIM 16/20: LOT: 4918, 1119 7 BIM 14/10: LOT: 4918, 3019 8 BIM 14/15: LOT: 4918 9 BIM 14/20: LOT: 4918 - 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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