FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Merit MAK Mini Access Kit, 4 French (1.3mm)
- Recall number
- Z-1309-04
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Merit MAK Mini Access Kit, 4 French (1.3mm)
- Status
- Terminated
- Initiated
- 2004-07-20
- Posted
- 2004-08-04
- Terminated
- 2005-01-21
- Reason
- Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
- Root cause
- Other
- Action
- Consignees were notified by phone and letter on 7/20/2004.
- Quantity
- 1164 kits
- Distribution
- Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
- Lot, serial or model codes
- Catalog Number MAK401, Lot Numbers: G322819, M9337627, MR314384, MR314386, MR317164, MR320056.
- 510(k) numbers
- ["K031691"]
- PMA numbers
- not on file
- Product code
- DRE
- 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