CLINICAL LASERTHERMIA SYSTEMS AB Scheelevagen 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

single use devices labeled as sterile may not have been adequately sterilized

Recommended Action

Per FDA guidance

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 lotio.ljungberg@clinicolloser.com. 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.