Reported Jun 9, 2021 · Terminated
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device…
Clinical Laserthermia Systems Ab
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: CLINICAL LASERTHERMIA SYSTEMS AB · Scheelevagen 2 · Lund · N/A
Is this the product you have?
- Tranberg MR Cannula
- REF4013-05, Rx Only
- Sterile EO - Product Usageused with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue
- Lot codes and dates
- Lot ID116539201117 and 116539030718 M
- Amount recalled
- 40 units
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
Why it was recalled
single use devices 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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