The Recall Desk
HighFDA (Devices)·Z-1781-2021·Announced 2021-06-09

Tranberg MR Stylet Recalled Due to Inadequate Sterilization

CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylet devices (lot IDs 116540030718 and 116540201117) because single-use units labeled as sterile may not have been adequately sterilized, creating infection risk.

What this means for you

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 of a medical device used in invasive therapeutic procedures. The hazard—inadequate sterilization—presents a significant risk of infection, but no illnesses or injuries have been reported in the source. This meets the criterion for High: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CLINICAL LASERTHERMIA SYSTEMS AB is recalling the Tranberg MR Stylet (1.8mm/15G, 230mm, REF: 4013-06), a single-use sterile medical device used with the Tranberg MR Introducer to aid insertion of a laser applicator into tissue.

The devices may not have been adequately sterilized despite being labeled as sterile and intended for single use. This poses a potential risk of infection or contamination to patients.

Affected lot IDs are 116540030718 and 116540201117. The recalled units were distributed worldwide to facilities in Texas, Maryland, and California in the United States, as well as to Canada, Germany, and Switzerland. Healthcare providers and facilities with these devices should immediately stop using them and contact CLINICAL LASERTHERMIA SYSTEMS AB for instructions on return or disposal. Patients who may have been treated with these devices should consult their healthcare provider regarding the recall.

The recalled product

Product
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, 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
Category
Medical Device — Surgical Instrument
Hazard
  • inadequate-sterilization
  • infection-risk

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 (2)

  • Lot ID: 116540030718
  • 116540201117

Distribution

Distributed nationwide across the United States.

Related recalls

Same category