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Class 2 Device Recall Disposable Sampling Tube and Sterile Saline |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
March 11, 2021 |
Create Date |
April 13, 2021 |
Recall Status1 |
Terminated 3 on November 16, 2022 |
Recall Number |
Z-1422-2021 |
Recall Event ID |
87595 |
Product Classification |
Culture media, non-propagating transport - Product Code JSM
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Product |
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
Krishe Inc 8105 Razor Blvd Ste 213 Plano TX 75024
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For Additional Information Contact |
Mr. Vipul Tailor 734-748-9580
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Manufacturer Reason for Recall |
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
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FDA Determined Cause 2 |
Other |
Action |
Krishe sent a "Urgent: Medical Device Recall" dated 3/11/21 via to all affected consignees via Fed Ex. In addition to informing consignees about the recall the firm ask consignees to take the following actions:
1. If you have any of the virus transport medium tubes, please immediately stop selling and using them. Please place them in quarantine and follow the instruction for return and credit that accompany this letter.
2. Please complete the attached acknowledgement and receipt form and return within 5 business days. If you do not have any of the recall product, we ask that you still completed the form and return it within 5 days.
3. If you have any questions, or for a return authorization, please contact Vipul Tailor, via telephone at 734-748-9580 or email vipul@krishelimited.com.
4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse event Reporting program either online by regular mail or by fax. |
Quantity in Commerce |
18,000 units |
Distribution |
US: LA, TX, FL, GA |
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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