FDA Medical Device Recalls (openFDA)
Ascent Healthcare Solutions, Inc.: AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
- Recall number
- Z-0414-2007
- Recalling firm
- Ascent Healthcare Solutions, Inc.
- Product
- AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
- Status
- Terminated
- Initiated
- 2006-10-19
- Posted
- 2007-02-08
- Terminated
- 2008-10-31
- Reason
- The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.
- Root cause
- Process design
- Action
- The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.
- Quantity
- 1566
- Distribution
- Nationwide
- Lot, serial or model codes
- 94724 95261 104057 94853 95272 104217 94893 100062 104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851 105517 94962 103100 94964 103103 95024 103200 95026 103288 95029 103293 95069 103297 95135 103566 95259 103570
- 510(k) numbers
- ["K043594"]
- PMA numbers
- not on file
- Product code
- NLM
- Firm FEI
- 1000132435
- Firm city
- Lakeland
- Firm state
- FL
- 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