The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1782-2021·Announced 2021-06-09

Tranberg Laser Applicator Devices Recalled Due to Inadequate Sterilization

Clinical Laserthermia Systems recalls 90 units of Tranberg Laser Applicator devices distributed worldwide because single-use sterile devices may not have been adequately sterilized.

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 FDA Class II recall involves failure of critical sterilization processes for a surgical medical device, creating significant risk of serious infection if contaminated devices are used. No illnesses or injuries have been reported, which limits the score to at most 3 per the rubric criterion for risk-of-harm products without confirmed injury.

Plain-English summary

Clinical Laserthermia Systems AB is recalling 90 units of Tranberg Laser Applicator Non-cooled devices (1.7mm/15G, 15mm Diffuser, REF: 4017-02). These are single-use, sterile medical devices used with the Tranberg MR Introducer to aid insertion of the laser applicator into tissue during surgical procedures.

The manufacturer identified that the affected devices labeled as sterile may not have been adequately sterilized during manufacturing. This creates a potential risk of bacterial or microbial contamination that could lead to infection if the device is used in clinical settings.

The recalled devices were distributed worldwide, including in the United States (Texas, Maryland, California), Canada, Germany, and Switzerland. The affected lot numbers are: 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, and 00049/2020/02.

Healthcare facilities and users in possession of affected devices should verify their device lot numbers and take appropriate action in consultation with the manufacturer and relevant regulatory authorities.

The recalled product

Product
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, 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 Laser
Hazard
Affected units
90

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 (6)

  • Lot # 00247/2019/11
  • 00029/2020/02
  • 00076/2020/03
  • 00177/2018/10-1
  • 00177/2018/10-2
  • 00049/2020/02

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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 →

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