Recall Z-1782-2021 ยท GEX Powered Laser Surgical Instrument
CLINICAL LASERTHERMIA SYSTEMS AB
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.
| Date | Apr 1, 2021 |
| Status | Terminated |
| Reason | single use devices labeled as sterile may not have been adequately sterilized |
| 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 lotio.ljungberg@clinicolloser.com. 2. According to our documentation we hove shipped the concerned products to you. 3. We request you collect all concern |
| Quantity | 90 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland. |
| FDA record | Open on fda.gov |