FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
- Recall number
- Z-2197-2008
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
- Status
- Terminated
- Initiated
- 2008-03-14
- Posted
- 2008-09-11
- Terminated
- 2008-09-09
- Reason
- Component of convenience kit may not be sterile.
- Root cause
- Packaging
- Action
- The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349.
- Quantity
- 36 kits
- Distribution
- PA. No military, government, or foreign distribution.
- Lot, serial or model codes
- Lot Number V583783
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- 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