| Class 2 Device Recall MR Stylet | |
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 |
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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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