FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K10-01047.
- Recall number
- Z-0142-04
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K10-01047.
- Status
- Terminated
- Initiated
- 2003-10-01
- Posted
- 2003-11-19
- Terminated
- 2004-02-02
- Reason
- There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Root cause
- Other
- Action
- Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.
- Quantity
- 30 units
- Distribution
- Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
- Lot, serial or model codes
- Lot # A289183
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQO
- 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