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U.S. Department of Health and Human Services

Class 2 Device Recall MR Stylet

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  Class 2 Device Recall MR Stylet see related information
Date Initiated by Firm April 01, 2021
Create Date June 04, 2021
Recall Status1 Terminated 3 on August 30, 2023
Recall Number Z-1781-2021
Recall Event ID 87808
Product Classification Cannula, surgical, general & plastic surgery - Product Code GEA
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.
Code Information Lot ID: 116540030718, 116540201117
Recalling Firm/
Manufacturer		 CLINICAL LASERTHERMIA SYSTEMS AB
Scheelevagen 2
Lund Sweden
Manufacturer Reason
for Recall		 single use devices labeled as sterile may not have been adequately sterilized
FDA Determined
Cause 2		 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 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 40 units
Distribution Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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