Z-1782-2021Class II

Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO -

Name: Z-1782-2021 Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO -
Creator: Clinical Laserthermia Systems Ab
Published: 2021-04-01
License: https://open.fda.gov/license/

Clinical Laserthermia Systems AB / initiated 2021-04-01 / Terminated / root cause: manufacturing process

FDA source

CLINICAL LASERTHERMIA SYSTEMS AB began a recall of 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... on 2021-04-01. FDA classified it as Class II and gives the reason as "single use devices labeled as sterile may not have been adequately sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1782-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-01
Posted: 2021-06-04
Terminated: 2023-08-30
Recalling firm: Clinical Laserthermia Systems AB
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.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: single use devices labeled as sterile may not have been adequately sterilized
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On April 1, 2021, CLS issued a "Field Safety Notice" concerning recalled product. In addition to informing consignees about the recall product, the firm asked consignees to take the following actions: 1. Please confirm upon receiving this letter that you hove taken port of the information in this field safety notice and forwarded a copy to relevant personnel within your organization by emailing the filled in reply form (appendix 1 ) to [email protected]. 2. According to our documentation we hove shipped the concerned products to you. 3. We request you collect all concerned products remaining in your stock. We also request you to contact your customers/end users without delay to whom you hove distributed concerned products to, informing them about the product recall. You con use the information written in the first section of this letter. If the customer still has products in their stock, they should return these to you of their earliest convenience. 4. Furthermore, we request you to return all collected products from you and your customers' stock to CLS before 2021-04-30, Attention to Lotto Ljungberg, (the address is found below in this letter). All additional costs for this collection and return of products will be covered by CLS. 5. Please inform us how many products you will return by 4/15/21. Fill in the lower part of Appendix I when you hove identified the number of remaining products in you and your customer's stock.
Quantity in commerce: 90 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
Product codes and lots: Lot # 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00049/2020/02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1782-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1780-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-03
Z-1781-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-03
Z-1782-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-03

Product code GEX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)