FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: 10 ml Inject 10 Palm Pad, sterile
- Recall number
- Z-0049-05
- Recalling firm
- Merit Medical Systems, Inc
- Product
- 10 ml Inject 10 Palm Pad, sterile
- Status
- Terminated
- Initiated
- 2004-09-14
- Posted
- 2004-10-28
- Terminated
- 2005-03-31
- Reason
- Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- Root cause
- Other
- Action
- All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.
- Quantity
- 25 syringes
- Distribution
- Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
- Lot, serial or model codes
- Product Number CCXB010/A, Lot Number A337459.
- 510(k) numbers
- ["K875196"]
- PMA numbers
- not on file
- Product code
- FMF
- 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