FDA Medical Device Recalls (openFDA)
Krishe Inc: Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
- Recall number
- Z-1422-2021
- Recalling firm
- Krishe Inc
- Product
- Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
- Status
- Terminated
- Initiated
- 2021-03-11
- Posted
- not on file
- Terminated
- 2022-11-16
- Reason
- Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
- Root cause
- 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
- 18,000 units
- Distribution
- US: LA, TX, FL, GA
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSM
- Firm FEI
- 3018098283
- Firm city
- Plano
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28