Tranberg MR Cannula: Inadequate Sterilization May Compromise Safety
CLINICAL LASERTHERMIA SYSTEMS AB is recalling the Tranberg MR Cannula due to potentially inadequate sterilization of certain lots. Affected units were distributed to medical facilities in the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for inadequate sterilization of single-use medical devices designed for internal use, creating a risk of infection and patient harm. Although no illnesses have been reported, the potential hazard is significant for sterility-critical devices.
Plain-English summary
The Tranberg MR Cannula (REF: 4013-05) is a single-use, sterile medical device designed for use with the Tranberg MR Introducer to assist in insertion of a laser applicator into tissue. It is labeled as sterile and for prescription use only.
Clinical Laserthermia Systems AB initiated this recall after determining that certain lots of these devices labeled as sterile may not have been adequately sterilized. The affected lots are 116539201117 and 116539030718 M, totaling 40 units.
These devices were distributed worldwide to medical facilities in Texas, Maryland, and California, as well as in Canada, Germany, and Switzerland. Healthcare providers who have received devices from the affected lots should not use them and should contact their supplier for instructions on proper return or destruction.
The recalled product
- Product
- Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
- Manufacturer
- CLINICAL LASERTHERMIA SYSTEMS AB
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot ID: 116539201117 and 116539030718 M
Distribution
Part of a larger recall action
This product is one of 3 recalled by CLINICAL LASERTHERMIA SYSTEMS AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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