FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
- Recall number
- Z-0027-2020
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
- Status
- Terminated
- Initiated
- 2018-10-26
- Posted
- not on file
- Terminated
- 2020-06-12
- Reason
- Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
- Root cause
- Error in labeling
- Action
- On 10/26/2018, Merit customer service representative placed telephone calls to consignees to inform them of the latex contained in the kits/trays. On 10/29/2018, the firm sent an "Urgent Product recall Notice" to all affected consignees via FedEx. The recall notification informed customers of the following: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed CRF to response@merit.com within 10 business days. 5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF. 6. If you have any questions concerning this communication, please contact Merit Customer service at (801) 208-4381 or by email at response@merit.com.
- Quantity
- 24 kits
- Distribution
- U.S.: VA, IL
- Lot, serial or model codes
- Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OES
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- 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